Label: NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled
- NDC Code(s): 69452-427-10, 69452-427-17, 69452-427-79
- Packager: BIONPHARMA INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 21, 2024
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- 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.
This product is not manufactured or distributed by the owners of Unisom ® SleepGels ®.
Manufactured for:
Bionpharma Inc.
Princeton, NJ 08540
Made in India
L0000778
R0124
Mfg. Lic. No.: TN00002123
2620515
Lot No.:
Exp. Date:
- 160's count
-
INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP-AID
diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69452-427 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:69452-427-79 160 in 1 BOTTLE; Type 0: Not a Combination Product 03/21/2024 2 NDC:69452-427-17 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/21/2024 3 NDC:69452-427-10 32 in 1 BOTTLE; Type 0: Not a Combination Product 03/21/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 03/21/2024 Labeler - BIONPHARMA INC. (079637826) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations SOFTGEL HEALTHCARE PRIVATE LIMITED 675584180 manufacture(69452-427)