Label: SLEEP AID- diphenhydramine hcl capsule
- NDC Code(s): 21130-860-32, 21130-860-96
- Packager: Safeway, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: 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.
Drug Label Information
Updated March 2, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Use
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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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO Unisom® SleepGels® active ingredient†
Sleep-Aid Softgels
DIPHENHYDRAMINE HCL 50 mg
Nighttime Sleep-Aid
- Non habit-forming
- Fall asleep fast
- Sleep soundly
- Wake up refreshed
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 Chattem, Inc., distributor of Unisom® SleepGels®.
DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
- Package Label
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INGREDIENTS AND APPEARANCE
SLEEP AID
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-860 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color blue Score no score Shape CAPSULE Size 13mm Flavor Imprint Code P50 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-860-32 1 in 1 BOX 11/29/2019 1 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:21130-860-96 96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 11/29/2019 Labeler - Safeway, Inc. (009137209)