drug facts
b8757d18-6c7d-45de-925a-e2814625f749
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Nighttime sleep-aid
Description
Diphenhydramine HCl 50 mg
Medication Information
Purpose
Nighttime sleep-aid
Directions
- adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Other Information
- store between 15-30ºC (59-86ºF)
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol, sorbitan, white ink
Description
Diphenhydramine HCl 50 mg
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
†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAPIS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
Use
for relief of occasional sleeplessness.
Do Not Use
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Product Label
Questions Or Comments?
Call 1-800-935-2362 Monday-Friday 9AM-5PM EST
When Using This Product
avoid alcoholic drinks.
Ask A Doctor Before Use If
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
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.
Active Ingredient (in Each Softgel)
Diphenhydramine HCl 50 mg
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
Structured Label Content
Purpose
Nighttime sleep-aid
Directions
- adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Other Information (Other information)
- store between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)
FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol, sorbitan, white ink
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
†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAPIS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
Use
for relief of occasional sleeplessness.
Do Not Use (Do not use)
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Product Label
Questions Or Comments? (Questions or comments?)
Call 1-800-935-2362 Monday-Friday 9AM-5PM EST
When Using This Product (When using this product)
avoid alcoholic drinks.
Ask A Doctor Before Use If (Ask a doctor before use if)
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)
ask a health professional before use.
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.
Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))
Diphenhydramine HCl 50 mg
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking sedatives or tranquilizers.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:59.847294 · Updated: 2026-03-14T23:02:50.389879