Nighttime Sleep Aid DIPHENHYDRAMINE HCL TOP CARE (TOPCO ASSOCIATES LLC) FDA Approved Use for relief of occasional sleeplessness.
FunFoxMeds box
Route
ORAL
Applications
M010

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each softgel) Diphenhydramine HCl 50 mg
Inactive Ingredients
Inactive ingredients FD&C blue #1 gelatin glycerin lecithin light mineral oil mannitol polyethylene glycol purified water sorbitol sorbitan white ink
Strengths
50 mg
Treats Conditions
Use For Relief Of Occasional Sleeplessness
Pill Appearance
Shape: capsule Color: blue Imprint: PC5

Identifiers & Packaging

Container Type BOX
UPC
0036800114173
UNII
TC2D6JAD40
Packaging

Principal Display Panel COMPARE TO THE ACTIVE INGREDIENT UNISOM® SLEEPGELS®† NIGHTTIME Sleep Aid DIPHENHYDRAMINE HCI 50 mg • NIGHTTIME SLEEP-AID Fall Asleep Fast Sleep Soundly Wake Up Refreshed SOFTGELS Liquid Filled Capsules TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. **This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®. DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 www.topcarebrand.com; Package Label TOPCARE HEALTH Nighttime Sleep Aid Diphenhydramine HCl 50 mg

Package Descriptions
  • Principal Display Panel COMPARE TO THE ACTIVE INGREDIENT UNISOM® SLEEPGELS®† NIGHTTIME Sleep Aid DIPHENHYDRAMINE HCI 50 mg • NIGHTTIME SLEEP-AID Fall Asleep Fast Sleep Soundly Wake Up Refreshed SOFTGELS Liquid Filled Capsules TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. **This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®. DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 www.topcarebrand.com
  • Package Label TOPCARE HEALTH Nighttime Sleep Aid Diphenhydramine HCl 50 mg

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 a 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 (1-800-222-1222) right away.
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 drinks.

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 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 (1-800-222-1222) right away.

Storage & Handling

Other information store between 15-30°C (59°-86°F)


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