Label: NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled
- NDC Code(s): 46122-775-64
- Packager: AMERISOURCE BERGEN
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 22, 2024
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 capsule)
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast- feeding,
- Keep out of reach of children.
- 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
Distributed By
AmerisourceBergen
1 West First Ave
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.comABC#: 10287782 Rev: 04/24
†This product is not manufactured or distributed by the owners of Unisom® SleepGels®.
Mfg. Lic. No.: TN00002123
Made in India
T00186R0324
L0000797
R0324
Lot No.:
Exp. Date: - 60's count
-
INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP-AID
diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-775 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 POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SORBITAN (UNII: 6O92ICV9RU) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) Product Characteristics Color blue Score no score Shape OVAL Size 13mm Flavor Imprint Code B50 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-775-64 1 in 1 CARTON 04/11/2024 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 04/11/2024 Labeler - AMERISOURCE BERGEN (007914906) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations SOFTGEL HEALTHCARE PRIVATE LIMITED 675584180 manufacture(46122-775)