Diphenhydramine HCl 25mg

Diphenhydramine HCl 25mg is an FDA drug label for the active ingredient SLEEP AID manufactured by Allegiant Health 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 20211123.

Generic: SLEEP AID

Manufacturer: Allegiant Health

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 69168-002

Application: M010

Effective: 20211123

Active Ingredients: Active ingredient(s) Diphenhydramine HCl 25 mg

Indications & Usage

Use(s) for relief of occasional sleeplessness

Dosage & Administration

Directions adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years of age: do not use

Contraindications

Not available.

Warnings

Warnings Do not use In children under 12 years of age With any other product containing diphenydramine, even one used on skin Ask a doctor before use if 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 avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center right away.

Adverse Reactions