Mouth & Lip preparations (topical)

DOSAGE FORMS AND STRENGTHS:
Supplied: [paste 5%] 

SOURCE:
Package insert data:

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DOSAGE AND ADMINISTRATION:
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• adults and children 2 years and older: gently dab paste on the site of irritation with a cotton swab or fingertip
• allow to remain in place at least 1 minute and then spit out
• use up to 4 times daily or as directed by a dentist or physician
• children under 12 years of age should be supervised in the use of the product
• children under 2 years of age: consult a dentist or physician

WARNINGS AND PRECAUTIONS:

Warnings
Do not use for more than 7 days unless directed by a dentist or physician or  if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

When using this product
-do not exceed recommended dosage
-avoid contact with eyes
-localized allergic reactions may occur after prolonged or repeated use

Stop use and ask a doctor if
-sore mouth symptoms do not improve in 7 days
-swelling, rash or fever develops
-irritation, pain or redness persists or worsens

DOSAGE FORMS AND STRENGTHS:
Benzocaine 20% (paste)

Other:
[ Aerosol (oral spray): Hurricaine® 20%;  Gel (oral):  Anbesol® 6.3%, Orajel® 7.5%, Anbesol/Orajel Maximum strength-20%, Orabase-B 20%. Zilactin-B 10%;  
Oral Liquid: Anbesol (6.3%), Orasol, Hurricaine (20%). Dental protective paste - Apply 3-4 times daily as needed. ]

SOURCE:
Package insert data:

• canker sore
• minor wounds or gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums
• aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

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DOSAGE AND ADMINISTRATION:
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Directions
replace tip on bottle when not in use

Adults and children 2 years and older:
use up to 4 times daily after meals and at bedtime or as directed by dentist or doctor

For direct application:
-do not dilute
-apply several drops directly from bottle onto affected area
-spit out after 2 to 3 minutes

As a mouthwash (oral rinse):
-place 10 to 20 drops onto tongue
-mix with saliva
-swish around in the mouth over the affected area for at least 1 minute and spit out

Children under 12 years: should be supervised in the use of this product

WARNINGS AND PRECAUTIONS:
Do not  use this product for more than 7 days unless directed by a dentist or doctor.

• When using this product:
  do not swallow
• avoid contact with eyes

Stop use and ask a doctor if:

• swelling, rash or fever develops
• irritation, pain, or redness persists or worsens
• sore mouth symptoms do not improve in 7 days

DOSAGE FORMS AND STRENGTHS:
Gly-Oxide LIQUID
(Carbamide peroxide 10%) Non USP*
ANTISEPTIC ORAL CLEANSER
½ FL OZ (15 mL)

SOURCE:
Package insert data:

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DOSAGE AND ADMINISTRATION:
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Press a small dab (about 1/4 inch) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film. Do not rub in. Attempting to spread this preparation may result in granular, gritty sensation and cause it to crumble. After application, however, a smooth, slippery film develops.

The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night. Depending on the severity of symptoms, it may be necessary to apply the preparation two or three times a day, preferably after meals. If significant repair or regeneration has not occurred in seven days, further investigation is advisable.

CONTRAINDICATIONS:
Oralone® is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

DOSAGE FORMS AND STRENGTHS:
Oralone® (Triamcinolone Acetonide Dental Paste USP, 0.1%) is supplied in tubes containing 5 g of dental paste (NDC 51672–1335-5) and 7.5 g of dental paste (NDC 51672–1335-8).

Storage
Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Mfd. by: Taro Pharmaceuticals Inc.

SOURCE:
Package insert data:

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DOSAGE AND ADMINISTRATION:
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Directions

• Apply to affected area (one spray)
• Allow to remain in place for at least 15 seconds, then spit out
• Use every 2 hours or as directed by a doctor or dentist
• Adults and children 12 years of age and older: For each application, spray 5 times.
• Children under 12 years of age: Should be supervised in use of this product.
• Children under 3 years of age: Ask a doctor or dentist

Other Information
Store between 59°F and 86°F (15°C - 30°C).
Tamper Evident: Do not use if blister package with "Chloraseptic®" name has been disturbed or opened.
Check expiration date before using.

WARNINGS AND PRECAUTIONS:
Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

When using this product
do not exceed recommended dosage.

Stop use and ask a doctor or dentist if
-sore mouth symptoms do not improve in 7 days
-irritation, pain or redness persists or worsens
-swelling, rash or fever develops

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

DOSAGE FORMS AND STRENGTHS:
Chloraseptic® Phenol/Oral Anesthetic

Active Ingredients: Phenol (1.4%). Inactive Ingredients: Blue 1, Flavor, Glycerin, Purified Water, Saccharin Sodium.

SOURCE:
Package insert data:

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DOSAGE AND ADMINISTRATION:
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Peridex therapy should be initiated directly following a dental prophylaxis. Patients using Peridex should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 15ml (marked in cap) of undiluted Peridex. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using Peridex. Peridex is not intended for ingestion and should be expectorated after rinsing.

CONTRAINDICATIONS:
Peridex should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

WARNINGS AND PRECAUTIONS:
WARNINGS
The effect of Peridex on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in Peridex users compared with control users. It is not known if Peridex use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine.

PRECAUTIONS------------------------------
General
1]  For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with Peridex should not be used as a major indicator of underlying periodontitis.
2]  Peridex can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in toothstaining. In clinical testing, 56% of Peridex users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of Peridex users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from use of Peridex does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis. Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from Peridex treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations.
3]  Some patients may experience an alteration in taste perception while undergoing treatment with Peridex. Rare instances of permanent taste alteration following Peridex use have been reported via post-marketing product surveillance.

Pregnancy
Teratogenic Effects

Pregnancy Category B
Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300mg/kg/day and 40mg/kg/day, respectively, and have not revealed evidence of harm to fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Peridex is administered to nursing women. In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than that which would result from a person's ingesting 30ml (2 capfuls) of Peridex per day.

Pediatric Use
Clinical effectiveness and safety of Peridex have not been established in children under the age of 18.

Carcinogenesis, Mutagenesis, Impairment of Fertility
In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagenesis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000mg/kg/day and 250mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100mg/kg/day.

ADVERSE REACTIONS:
The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception, see WARNINGS and PRECAUTIONS. Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with Peridex are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using Peridex. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using Peridex.

DOSAGE FORMS AND STRENGTHS:
Peridex is supplied as a blue liquid in the following sizes:

0.5 fluid ounce (15 ml) (NDC 48878-0620-4) amber plastic bottle with child resistant dispensing closure
4 fluid ounce (118 ml) (NDC 48878-0620-3) amber plastic bottles with child resistant dispensing closure
16 fluid ounce or 1 pint (473ml) (NDC 48878-0620-1) amber plastic bottles with child-resistant dispensing closure
64 fluid ounce (1893 ml) (NDC 48878-0620-2) white plastic bottle with pump dispensing closure

STORE at 20°C to 25°C (68°F to 77°F ), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].

Rx only

Keep out of reach of children

SOURCE:
Package insert data:

Mycelex® Troches are also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence.

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DOSAGE AND ADMINISTRATION:
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Mycelex® Troches are administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one troche five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole troche after prolonged administration; therefore, therapy should be limited to short term use, if possible.

For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation, the recommended dose is one troche three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.

WARNINGS AND PRECAUTIONS:
WARNING
Mycelex® Troches are not indicated for the treatment of systemic mycoses including systemic candidiasis.

PRECAUTIONS
Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials. In most cases the elevations were minimal and it was often impossible to distinguish effects of clotrimazole from those of other therapy and the underlying disease (malignancy in most cases). Periodic assessment of hepatic function is advisable particularly in patients with pre-existing hepatic impairment.

Since patients must be instructed to allow each troche to dissolve slowly in the mouth in order to achieve maximum effect of the medication, they must be of such an age and physical and/or mental condition to comprehend such instructions.

Carcinogenesis:
An 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect.

Usage in Pregnancy: Pregnancy Category C:
Clotrimazole has been shown to be embryotoxic in rats and mice when given in doses 100 times the adult human dose (in mg/kg), possibly secondary to maternal toxicity. The drug was not teratogenic in mice, rabbits, and rats when given in doses up to 200, 180, and 100 times the human dose.

Clotrimazole given orally to mice from nine weeks before mating through weaning at a dose 120 times the human dose was associated with impairment of mating, decreased number of viable young, and decreased survival to weaning. No effects were observed at 60 times the human dose. When the drug was given to rats during a similar time period at 50 times the human dose, there was a slight decrease in the number of pups per litter and decreased pup viability.

There are no adequate and well controlled studies in pregnant women. Clotrimazole troches should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE
Safety and effectiveness of clotrimazole in children below the age of 3 years have not been established; therefore, its use in such patients is not recommended.

The safety and efficacy of the prophylactic use of clotrimazole troches in children have not been established.

GERIATRIC USE
Clinical studies of clotrimazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

DOSAGE FORMS AND STRENGTHS:
Mycelex® Troches, white discoid, uncoated tablets are supplied in bottles of 70 and 140. Mycelex® Troches are also available for institutional use in foil packages of 70 tablets. Each tablet will be identified with the following: Mycelex 10. Strength: 10mg

SOURCE:
Package insert data:

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DOSAGE AND ADMINISTRATION:
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Infants: 2 mL (approximately ½ teaspoon) (200,000 units) four times daily. Place one-half of dose, 1 mL (approximately ¼ teaspoon), in each side of mouth and avoid feeding for 5 to 10 minutes.

NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

Children and Adults: 4-6 mL (approximately 1 teaspoon) (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.

Continue treatment for at least 48 hours, after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

CONTRAINDICATIONS:
The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

WARNINGS AND PRECAUTIONS:
PRECAUTIONS

General
This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy
Teratogenic Effects

Category C: Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.

Nursing Mothers
It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

Pediatric Use
See DOSAGE AND ADMINISTRATION.

DOSAGE FORMS AND STRENGTHS:
Nystatin Oral Suspension, USP is available as a yellow, cherry-flavored, pleasant-tasting, ready-to-use suspension containing 100,000 USP Nystatin Units per mL in 60 mL bottles (supplied with a calibrated dropper), 8 oz (237 mL) bottles (supplied with dose cup) and one pint (473 mL) bottles.

SHAKE WELL BEFORE USING.

Store at controlled room temperature 59°-86°F (15°-30°C). Avoid freezing.

Dispense in a tight, light-resistant container as defined in the USP.

SOURCE:
Package insert data:

When using this product

•

apply only to affected areas

•

do not use in or near the eyes

•

avoid applying directly inside your mouth

•

do not share this product with anyone. This may spread infection.

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DOSAGE AND ADMINISTRATION:
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Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days

Adults and children 12 years or over:

>wash hands before and after applying cream
>apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle).
>early treatment ensures the best results
>rub in gently but completely
>use 5 times a day until healed

children under 12 years: ask a doctor

DOSAGE FORMS AND STRENGTHS:
Abreva®
DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment
Only FDA Approved to Shorten Healing Time*
Cold Sore Treatment
NET WT
2g (.07 oz)

SOURCE:
Package insert data:

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DOSAGE AND ADMINISTRATION:
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Denavir should be applied every 2 hours during waking hours for a period of 4 days. Treatment should be started as early as possible (i.e., during the prodrome or when lesions appear).

CONTRAINDICATIONS:
Denavir is contraindicated in patients with known hypersensitivity to the product or any of its components.

DOSAGE FORMS AND STRENGTHS:
Denavir is supplied in a 1.5 gram tube containing 10mg of penciclovir per gram.

NDC 0067-6024-15
Store at controlled room temperature, 20°-25° C (68°-77°F) [see USP]

SOURCE:
Package insert data:

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DOSAGE AND ADMINISTRATION:
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Directions for Use: Pour the entire contents of the single-use Gelclair packet into a glass and add 1 tablespoon of water. If this dilution of Gelclair is too thick, it may be diluted with an additional 1-2 tablespoons of water to achieve the desired thickness. Stir mixture well and use immediately. Rinse around the mouth for at least 1 minute or as long as possible to coat tongue, palate, throat, inside of cheeks and all oral tissue thoroughly. Gargle and spit out. Use 3 time s a day or as needed. Do not eat or drink for at least 30-60 minutes following treatment. If water is not available, Gelclair may be used undiluted. If Gelclair is swallowed accidently, no adverse effects are anticipated.

CONTRAINDICATIONS:
The administration use of Gelclair is contraindicated in any patient with a known or suspected hypersensitivity to any of its ingredients.

WARNINGS AND PRECAUTIONS:
Special Precautions for Use: Avoid eating or drinking for at least 30-60 minutes after use. Do not use any packet that is not intact (torn, split, or otherwise damaged in any way). If no improvement is noticed after 7 days, consult a physician.

DOSAGE FORMS AND STRENGTHS:
Ingredients: Water, Maltodextrin, Propylene Glycol, Polyvinylprrolidone (PVP), Sodium Hyaluronate, Potassium Sorbate, Sodium Benzoate, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Disodium Edetate, Benzylkonium Chloride, Flavoring, Saccharin Sodium, Glycyrrhetinic Acid.

Pharmaceutical Form: Concentrated oral gel

Contents: 15 mL per single-use packet. Commercial boxes contain 15 single-use packets (NHRIC 89141-456-02)

Store at room temperature, out of direct sunlight. The gel may become a little darker and thicker over time, but this does not affect its efficacy or safety. Do not use after the expiration date shown on the box and packet.

SOURCE:
Package insert data:

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DOSAGE AND ADMINISTRATION:
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Adult
The maximum recommended single dose of LidocaineViscous (Lidocaine Hydrochloride Oral Topical Solution USP) for healthy adults should be such that the dose of lidocaine HCl does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient’s age, weight and physical condition (see package insert for PRECAUTIONS).

Pediatric
Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child’s weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3/4 to 1 teaspoonful).

For infants and in children under 3 years of age, 1/4 teaspoon of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

CONTRAINDICATIONS:
Lidocaine Viscous (Lidocaine Hydrochloride Oral Topical Solution USP) is contraindicated in patients with a known hypersensitivity (allergy) to the amide type of local anesthetics or to other components of the solution.

WARNINGS AND PRECAUTIONS:
WARNINGS
EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.

Lidocaine should be used with extreme caution if the mucosa in the area of application has been traumatized, since under such conditions there is the potential for rapid systemic absorption.

PRECAUTIONS

General
The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies (see WARNINGS and package insert for ADVERSE REACTIONS). The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug and/or its metabolites. Tolerance varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age, weight and physical condition. Lidocaine should also be used with caution in patients with severe shock or heart block.

Lidocaine should be used with caution in persons with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.

Information for Patients
When topical anesthetics are used in the mouth or throat, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating.

Numbness of the tongue or buccal mucosa may increase the danger of biting trauma. For this reason food and/or chewing gum should not be used while the mouth or throat area is anesthetized.

PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO DOSING INSTRUCTIONS, AND TO KEEP THE SUPPLY OF MEDICATION OUT OF THE REACH OF CHILDREN.

DOSAGE FORMS AND STRENGTHS:
Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)

NDC 0054-8500-16: Unit dose Patient Cup™ filled to contain 20 mL (deliver 15 mL), ten 20 mL Patient Cups™ per shelf pack, four shelf packs per shipper.

NDC 0054-3500-49: Squeeze bottle of 100 mL.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperatures]. Avoid freezing.

SHAKE WELL BEFORE USING.

SOURCE:
Package insert data:

Lidocaine: 6.7 mg/ml ; Benadryl: 0.83 mg/ml.

SHAKE WELL BEFORE USING.

Note: the most significant drug-induced adverse reactions are attributable to lidocaine. The lowest dosage that results in effective anesthesia should be used to avoid high plasma concentrations. Indications: Topical anesthesia of irritated or inflamed mucous membranes. Commonly used for radiation mucositis or chemotherapy-induced stomatitis. The mixture may be swallowed, however, if the inflammation is limited to the oral cavity the mixture should be swished around the mouth then expectorated. 

Dosing: (Guidelines based on maximum single dose of lidocaine 4.5 mg/kg- not to exceed 300 mg/dose. Max of 8 doses/day).  

Patient weight (45kg): 5 to 30 ml q3-6h prn (max 8 doses/day). 
Patient weight (50 to 55kg): 5 to 35 ml q3-6h as needed (max 8 doses/day). 
Patient weight (60kg): 5 to 40 ml q3-6h as needed (max 8 doses/day). 
Patient weight (65kg and above): 5 to 45 ml q3-6h as needed (max 8 doses/day).

• Saliva Substitute is used for immediate and effective relief of dry mouth and dry throat by moistening and lubricating.
   
• Dry mouth may be caused by certain medications, radiation therapy, some medical conditions, or aging.
   
• Saliva Substitute is safe and effective for relief of dry mouth and dry throat.
   
• Use as often as needed.
   
• Salivart Oral Moisturizer provides immediate moistening action for temporary relief of dry mouth (Xerostomia).
   
• It has a gentle aerosol applicator.
   
• Saliva Substitute, Oral Moisturizer contains no alcohol or glycerin and no artificial flavors or colors.
   
• It has no contraindications and can be used as often as needed.
   
• Dye and Salt Free.
   
• Saliva Substitute for Moisturising and lubricating the oral cavity.

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DOSAGE AND ADMINISTRATION:
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You can use this medicine as often as you need to or as directed by your doctor.

Moi-Stir^{® -} Adults: Spray 1 or 2 times into mouth whenever it feels uncomfortably dry.
Caution: Keep out of reach of children.
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Saliva substitute oral moisturizer for dry mouth relief - 120 ml (Roxanne):
DIRECTIONS
1.Aim nozzle at red dot.. 2.Discard first spray.
3.Hold Saliva Substitute Oral Moisturizer can extremely close to mouth (1 to 2 inches) and spray for 1/2 second or less to relieve dryness.
4.Hold can upright during use. Generic Salivart Oral Moisturizer may be used as often as needed.
5.It may be swallowed or expectorated.

DOSAGE FORMS AND STRENGTHS:
Generic Salivert:
Saliva substitute oral moisturizer for dry mouth relief - 120 ml
INGREDIENTS
Purified Water, Sorbitol, Sodium Carboxymethylcellulose, Potassium Chloride, Potassium Phosphate Dibasic, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate.

SOURCE:
Package insert data:

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DOSAGE AND ADMINISTRATION:
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Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

Head & Neck Cancer Patients: The recommended initial dose of SALAGEN® Tablets is 5 mg taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The usual dosage range is up to 15-30 mg per day. (Not to exceed 10 mg per dose.) Although early improvement may be realized, at least 12 weeks of uninterrupted therapy with SALAGEN® Tablets may be necessary to assess whether a beneficial response will be achieved. The incidence of the most common adverse events increases with dose. The lowest dose that is tolerated and effective should be used for maintenance.

Sjogren's Syndrome Patients: The recommended dose of SALAGEN® Tablets is 5 mg taken four times a day. Efficacy was established by 6 weeks of use.

CONTRAINDICATIONS:
SALAGEN® Tablets are contraindicated in patients with uncontrolled asthma, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.

WARNINGS AND PRECAUTIONS:
WARNINGS
Cardiovascular Disease: Patients with significant cardiovascular disease may be unable to compensate for transient changes in hemodynamics or rhythm induced by pilocarpine. Pulmonary edema has been reported as a complication of pilocarpine toxicity from high ocular doses given for acute angle-closure glaucoma. Pilocarpine should be administered with caution in and under close medical supervision of patients with significant cardiovascular disease.

Ocular: Ocular formulations of pilocarpine have been reported to cause visual blurring which may result in decreased visual acuity, especially at night and in patients with central lens changes, and to cause impairment of depth perception. Caution should be advised while driving at night or performing hazardous activities in reduced lighting.

Pulmonary Disease: Pilocarpine has been reported to increase airway resistance, bronchial smooth muscle tone, and bronchial secretions. Pilocarpine hydrochloride should be administered with caution to and under close medical supervision in patients with controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease requiring pharmacotherapy.

PRECAUTIONS

General
Pilocarpine toxicity is characterized by an exaggeration of its parasympathomimetic effects. These may include: headache, visual disturbance, lacrimation, sweating, respiratory distress, gastrointestinal spasm, nausea, vomiting, diarrhea, atrioventricular block, tachycardia, bradycardia, hypotension, hypertension, shock, mental confusion, cardiac arrhythmia, and tremors.

The dose-related cardiovascular pharmacologic effects of pilocarpine include hypotension, hypertension, bradycardia, and tachycardia.

Pilocarpine should be administered with caution to patients with known or suspected cholelithiasis or biliary tract disease. Contractions of the gallbladder or biliary smooth muscle could precipitate complications including cholecystitis, cholangitis, and biliary obstruction.

Pilocarpine may increase ureteral smooth muscle tone and could theoretically precipitate renal colic (or "ureteral reflux"), particularly in patients with nephrolithiasis.

Cholinergic agonists may have dose-related central nervous system effects. This should be considered when treating patients with underlying cognitive or psychiatric disturbances.

Hepatic Insufficiency: Based on decreased plasma clearance observed in patients with moderate hepatic impairment, the starting dose in these patients should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency (Child-Pugh score of 5-6) do not require dosage reductions. To date, pharmacokinetic studies in subjects with severe hepatic impairment (Child-Pugh score of 10-15) have not been carried out. The use of pilocarpine in these patients is not recommended.

Additional comments - See package insert.

DOSAGE FORMS AND STRENGTHS:
HOW SUPPLIED:

SALAGEN® Tablets, 5 mg, are white, film coated, debossed round tablets, coded SAL 5. Each tablet contains 5 mg pilocarpine hydrochloride. They are supplied as follows:

NDC 62856-705-10 bottles of 100

Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

SALAGEN® Tablets, 7.5 mg, are blue, film coated, debossed round tablets, coded SAL 7.5. Each tablet contains 7.5 mg pilocarpine hydrochloride. They are supplied as follows:

NDC 62856-775-10 bottles of 100

Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

SOURCE:
Package insert data:

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DOSAGE AND ADMINISTRATION:
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CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS:

DOSAGE FORMS AND STRENGTHS:

SOURCE:
Package insert data: