SLEEP AID DIPHENHYDRAMINE HYDROCHLORIDE SHIELD PHARMACEUTICALS CORP FDA Approved Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
FunFoxMeds box
Route
ORAL
Applications
M010
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each softgel) Diphenhydramine HCl 25 mg
Inactive Ingredients
Inactive ingredients FD&C Blue No. 1 FD&C Red No. 40 gelatin glycerin propylene glycol polyethylene glycol-400 povidone purified water sorbitol sorbitan solution
Strengths
25 mg
Treats Conditions
Uses For The Relief Of Occasional Sleeplessness Reduces Time To Fall Asleep If You Have Difficulty Falling Asleep
Pill Appearance
Shape: capsule Color: purple Imprint: SD13

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
TC2D6JAD40
Packaging

PRINCIPAL DISPLAY PANEL SLEEP-AID DIPHENHYDRAMINE HCl 25 mg Sleep Aid Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL SLEEP-AID DIPHENHYDRAMINE HCl 25 mg Sleep Aid Carton

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed take only one dose per day (24 hours) adults & children 12 yrs & over take 2 capsules at bedtime if needed or as directed by a doctor children under 12 years Do not use

Warnings & Precautions
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 asthma, emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers or any other sleep aid When using this product avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222
Purpose

Purpose nighttime sleep-aid

Do Not Use

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

When Using

When using this product avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222

Storage & Handling

Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) and high humidity Protect from light

Questions

Questions or comments? 1-800-373-6981 Distributed by: Shield Pharmaceuticals Corp. Hauppauge, NY 11788


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