Label: SLEEP AID NIGHTTIME- diphenhydramine hcl capsule
- NDC Code(s): 41163-860-32, 41163-860-96
- Packager: EQUALINE (SuperValu)
- 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 November 7, 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
- Uses
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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
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to Unisom® SleepGels® active ingredient**
maximum strength
Sleep-Aid softgels
diphenhydramine HCl, 50 mg
(nighttime Sleep-Aid)
- Fall asleep fast
- sleep soundly and wake up refreshed
- non habit-forming
liquid filled
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 CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY UNFI
PROVIDENCE, RI 02908 USA
- Product Label
-
INGREDIENTS AND APPEARANCE
SLEEP AID NIGHTTIME
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-860 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) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) 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:41163-860-96 96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/27/2019 2 NDC:41163-860-32 1 in 1 BOX 12/27/2019 2 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 12/27/2019 Labeler - EQUALINE (SuperValu) (006961411)