TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE TOPCO ASSOCIATES LLC FDA Approved Use • for relief of occasional sleeplessness

TOPCARE HEALTH NIGHTTIME MAXIMUM STRENGTH SLEEP AID

Generic: DIPHENHYDRAMINE HYDROCHLORIDE
Mfr: TOPCO ASSOCIATES LLC FDA OTC
FunFoxMeds box
Substance Diphenhydramine Hydrochloride
Route
ORAL
Applications
M010
Product NDC
76162-0438-00 76162-0438-96
Package NDC
76162-438-96

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each softgel) Diphenhydramine HCl 50 mg
Inactive Ingredients
Inactive ingredients FD&C blue No. 1 gelatin glycerin polyethylene glycol 400 propylene glycol sorbitol sorbitan anhydrous titanium dioxide
Strengths
50 mg
Treats Conditions
Use For Relief Of Occasional Sleeplessness

Identifiers & Packaging

Container Type UNKNOWN
NDC 76162-0438-00
All Product Codes
76162-0438-00 76162-0438-96
UNII
TC2D6JAD40
SPL Set IDs
2ea0b2cf-f055-11f6-e063-6394a90a5364
Packaging

Packaging NIGHTTIME MAXIMUM STRENGTH

Package Descriptions
  • Packaging NIGHTTIME MAXIMUM STRENGTH
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 persist 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 controlled room temperature 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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