Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76281-301-24 - Packager: AptaPharma Inc.
- Category: HUMAN OTC DRUG LABEL
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 October 28, 2019
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep out of reach of children
- Uses
- Warnings
- Ask a doctor before use if the child has
- Ask a doctor or pharmacist before use if the child is
- When using this product
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Product Label
SOUND BODY™
COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL® ALLERGY LIQUID*Relieves: Sneezing, Runny Nose, Itchy Watery Eyes, Itchy Throat
Children’s
Allergy
ReliefDiphenhydramine HCL Oral Solution Antihistamine
Alcohol-free
Cherry Flavor
4 FL OZ (118 mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Manufactured by:
AptaPharma Inc.
1533 Union Ave.
Pennsauken, NJ 08110V#5002632 ITEM#301
BX-034
LOT:
EXP:res
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INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY RELIEF
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-301 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 Score Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-301-24 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/21/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/21/2013 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-301)