Label: CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid
- NDC Code(s): 76281-505-24
- Packager: AptaPharma Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 30, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
Product Label
AP SAFE NDC 72681-505-24
COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN'S BENADRYL®
ALLERGY LIQUID*Children's
Allergy
ReliefDIPHENHYDRAMINE HCl
Liquid
AntihistamineRelieves: Sneezing,
Runny Nose,
Itchy Watery Eyes,
Itchy Throat• Alcohol-Free
4 FL OZ (118 mL) Cherry Flavor
DO NOT USE IF PRINTED SEAL
UNDER CAP IS TORN OR MISSING2
1013430
3/20*This product is not manufactured or
distributed by McNeil PPC, Inc., distributor
of Benadryl® Allergy liquid.Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110AP-BX-03
Carton
Bottle
res
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INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-505 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLOXAMER 407 (UNII: TUF2IVW3M2) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) Product Characteristics Color pink Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-505-24 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/30/2020 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-505)