Benadryl

Benadryl is an FDA drug label for the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE manufactured by Proficient Rx LP administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231201.

Generic: DIPHENHYDRAMINE HYDROCHLORIDE

Manufacturer: Proficient Rx LP

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 71205-521

Application: M012

Effective: 20231201

Active Ingredients: Active ingredient (in each tablet) Diphenhydramine HCl 25 mg

Indications & Usage

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

Dosage & Administration

Directions • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

Contraindications

Not available.

Warnings

Warnings Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Adverse Reactions

Not available.

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