RxNorm Names
Review RxNorm Normal Forms
SLEEP AID MAXIMUM STRENGTH
(diphenhydramine hcl)
capsule
[Care One (American Sales Company)]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=851e7e5f-14bd-480a-a775-9ac1ac854ff1| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Ask a doctor before use if you have
- emphysema
- chronic bronchitis
- glaucoma
- difficulty in urination due to an enlargement of the prostate gland
Stop use and ask a doctor if
- sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.Directions
- adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor
Other information
- Store at controlled room temperature 15°-30°C (59°-86°F)
- do not use if imprinted safety seal under cap is broken or missing
-
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®
Inactive ingredients
edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.Principal Display Panel
Compare to the Active Ingredient in Maximum Strength Unisom SleepGels®*
Maximum Strength
Sleep- Aid
Helps to reduce difficulty falling asleep
Diphenhydramine HCl 50 mg
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed by: American Sales Company
4201 walden avenue, Lancaster, NY 14086
© 2009 S&S BRANDS, INC.
Quality guaranteed or your money back
| SLEEP AID
MAXIMUM STRENGTH
diphenhydramine hcl capsule |
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| Labeler - Care One (American Sales Company) (809183973) |
| Registrant - P and L Development of New York Corporation (800014821) |
Revised: 12/2012
Document Id: a4f98a63-62b8-4b27-a9d6-5bbfbb80d611
Set id: 851e7e5f-14bd-480a-a775-9ac1ac854ff1
Version: 1
Effective Time: 20121227
Care One (American Sales Company)
