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Drug Description

BENADRYL® Allergy
(diphenhydramine) Tablets

DESCRIPTION

Benadryl® Allergy contains the histamine-blocker diphenhydramine. This product relieves: runny nose; sneezing; itchy, watery eyes; itchy throat.

Ingredient

Active ingredient
(in each capsule)
Purpose
Diphenhydramine HCl 25 mg Antihistamine

Inactive ingredients

candelilla wax, colloidal silicone dioxide, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, providone, pregelatinized starch, starch, stearic acid, titanium dioxide, and talc

* Effects seen on total nasal symptoms with Benadryl® Allergy (diphenhydramine) 50 mg 3 times daily. Use as directed.

Indications & Dosage

INDICATIONS

Benadryl® Allergy (diphenhydramine) Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

DOSAGE AND ADMINISTRATION

Directions

  • do not use more than directed (see OVERDOSE warning)

adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 capsules).
children 6 to under 12 years of age 12.5 mg ** to 25 mg (1 capsule).
children under 6 years of age consult a doctor

**12.5 mg dosage strength is not available in Benadryl (diphenhydramine) ® Allergy Kapseals® Capsules.

Other information

  • store at 59° to 77°F in a dry place
  • protect from light

HOW SUPPLIED

Available in:
Ultratabs® tablets: Box of 24's, 48's, & 100's
Kapseals® capsules: Box of 24's & 48's

FDA rev date: 7/1/1997

Side Effects & Drug Interactions

SIDE EFFECTS

When using this product:

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

DRUG INTERACTIONS

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Warnings & Precautions

WARNINGS

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

PRECAUTIONS

No information provided.

Overdosage & Contraindications

OVERDOSE

Overdose warning: Taking more than the recommended dose may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

CONTRAINDICATIONS

No information provided.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

No information provided.

Medication Guide

PATIENT INFORMATION

Do not use

  • with another product containing any of these active ingredients
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • with any other product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

  • heart disease
  • glaucoma
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • high blood pressure
  • a breathing problem such as emphysema or chronic bronchitis
  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

do not use more than directed

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • redness or swelling is present
  • sore throat is severe
  • you get nervous, dizzy, or sleepless
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain, cough or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
  • sore throat lasts for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.

Questions?

call 1-800-524-2624 (English/Spanish), weekdays, 9 AM - 5 PM EST.

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