CVS Health Nighttime Sleep Aid

CVS Health Nighttime Sleep Aid is an FDA drug label for the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE manufactured by CVS Pharmacy,Inc. 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 20171018.

Generic: DIPHENHYDRAMINE HYDROCHLORIDE

Manufacturer: CVS Pharmacy,Inc.

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 69842-753

Application: part341

Effective: 20171018

Active Ingredients: Active ingredient (in each 30 mL) Diphenhydramine HCl 50 mg

Indications & Usage

Uses • for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep

Dosage & Administration

Directions • take only one dose per day (24 hours) • Measure with dosing cup provided adults & children 12 yrs & over One Dose = 30 mL at bed time if needed or as directed by a doctor Children under 12 yrs do not use

Contraindications

Not available.

Warnings

Warnings Do not use • for children under 12 years of age • 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 • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • avoid alcoholic beverages Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. 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 at 1-800-222-1222.

Adverse Reactions

Not available.

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