DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL HEALTHCARE PVT LTD FDA Approved Uses for relief of occasional sleeplessness

DIPHENHYDRAMINE HYDROCHLORIDE

Generic: DIPHENHYDRAMINE HYDROCHLORIDE
Mfr: SOFTGEL HEALTHCARE PVT LTD FDA OTC
FunFoxMeds box
Substance Diphenhydramine Hydrochloride
Route
ORAL
Applications
M010
Product NDC
35916-0470-00 35916-0470-01
Package NDC
35916-0470-1

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each softgel) Diphenhydramine Hydrochloride USP 50 mg
Inactive Ingredients
Inactive ingredients gelatin glycerin polyethylene glycol 400 polyethylene glycol 600 purified water sorbitol sorbitan solution
Strengths
50 mg
Treats Conditions
Uses For Relief Of Occasional Sleeplessness
Pill Appearance
Shape: oval Color: white

Identifiers & Packaging

Container Type UNKNOWN
NDC 35916-0470-00
All Product Codes
35916-0470-00 35916-0470-01
UNII
TC2D6JAD40
SPL Set IDs
335b09c6-ee5d-ebdf-e063-6294a90abd12
Packaging

bulk label

Package Descriptions
  • bulk label
Overview

Uses for relief of occasional sleeplessness

Indications & Usage

Uses for relief of occasional sleeplessness

Dosage & Administration

Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Warnings & Precautions
Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin
Purpose

Purpose Nighttime sleep-aid

When Using

When using this product avoid alcoholic drinks

Stop Use & Ask a Doctor

Stop use and ask a doctor if sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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Additional Information

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