Sleep Aid Nighttime DIPHENHYDRAMINE HYDROCHLORIDE TOPCO ASSOCIATES LLC FDA Approved Use • for relief of occasional sleeplessness

SLEEP AID NIGHTTIME

Generic: DIPHENHYDRAMINE HYDROCHLORIDE
Mfr: TOPCO ASSOCIATES LLC FDA OTC
FunFoxMeds bottle
Substance Diphenhydramine Hydrochloride
Route
ORAL
Applications
M010
Product NDC
36800-0784-00 36800-0784-96
Package NDC
36800-784-96

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each softgel) Diphenhydramine HCl 50 mg
Inactive Ingredients
Inactive ingredients FD&C blue #1 FD&C red #40 gelatin glycerin polyethylene glycol povidone propylene glycol purified water sorbitol sorbitan solution titanium dioxide
Strengths
50 mg
Treats Conditions
Use For Relief Of Occasional Sleeplessness
Pill Appearance
Shape: oval Color: blue Imprint: 785

Identifiers & Packaging

Container Type BOTTLE
NDC 36800-0784-00
All Product Codes
36800-0784-00 36800-0784-96
UNII
TC2D6JAD40
SPL Set IDs
9f1c078d-e537-4ec0-8ae9-54c98282be29
Packaging

Packaging PRINCIPAL DISPLAY PANEL - 96 Softgel Bottle Label

Package Descriptions
  • Packaging PRINCIPAL DISPLAY PANEL - 96 Softgel Bottle Label
Overview

Use • for relief of occasional sleeplessness

Indications & Usage

Use • 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 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 avoid alcoholic drinks 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: In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Nighttime sleep-aid

Keep Out of Reach of Children

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

Storage & Handling

Other information store at 20°-25°C (68°-77°F)

Questions

Questions? Call toll free: 1-888-423-0139

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Additional Information

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