Label: NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled
- NDC Code(s): 46122-695-72
- Packager: AMERISOURCE BERGEN
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 10, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
-
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
■ a breathing problem such as emphysema or chronic bronchitis
■ difficulty in urination due to enlargement of the prostate glandWhen using this product
■ avoid alcoholic beverages
■ be careful when driving a motor vehicle or operating machinery - Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
SPL UNCLASSIFIED SECTION
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED
WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
Made in USA using domestic and imported materials.
†This product is not manufactured or distributed by the
owners of Unisom ® SleepGels ®.
Lot No.:
Exp. Date:
Distributed By
AmerisourceBergen
1 West First Ave
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.comL0000442
Rev # 04/21
- 60's Count Carton
-
INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP-AID
diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-695 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 GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Product Characteristics Color blue Score no score Shape OVAL Size 13mm Flavor Imprint Code P50 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-695-72 1 in 1 CARTON 07/15/2021 1 60 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 07/15/2021 Labeler - AMERISOURCE BERGEN (007914906) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Patheon Softgels Inc. 002193829 manufacture(46122-695)