Sleep Aid DIPHENHYDRAMINE HCL QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) FDA Approved Use for relief of occasional sleeplessness.
FunFoxMeds box
Route
ORAL
Applications
M010
Package NDC

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 sorbitan sorbitol white ink
Strengths
50 mg
Treats Conditions
Use For Relief Of Occasional Sleeplessness
Pill Appearance
Shape: oval Color: blue Imprint: PC5

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0635515996816
UNII
TC2D6JAD40
Packaging

Principal Display Panel †Compare to the Active Ingredient in Unisom® SleepGels® Sleep-Aid Maximum Strength Nighttime Sleep-Aid Diphenhydramine HCL 50 mg Help To Reduce Difficulty Falling Asleep Softgels 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 CDMA, Inc Novi, MI 48375; Package Label Quality Choice Maximum Strength Sleep-Aid Diphenhydramine HCl 50 mg

Package Descriptions
  • Principal Display Panel †Compare to the Active Ingredient in Unisom® SleepGels® Sleep-Aid Maximum Strength Nighttime Sleep-Aid Diphenhydramine HCL 50 mg Help To Reduce Difficulty Falling Asleep Softgels 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 CDMA, Inc Novi, MI 48375
  • Package Label Quality Choice Maximum Strength 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)

Questions

Questions or comments? Call 1 -800-935-2362 Monday-Friday 9AM-5PM EST


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