Label: CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid
- NDC Code(s): 21130-025-04
- Packager: Safeway, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 January 4, 2023
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 5 mL)
- Purpose
- Uses
-
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if the child has
- glaucoma
- a breathing problem such as chronic bronchitis
- a sodium-restricted diet
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Directions
- do not take more than 6 doses in 24 hours
- take every 4 to 6 hours, or as directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device
- mL = milliliter
- keep dosing cup with product
- find the right dose on the chart below
age (yr) dose (mL) children 6 to 11 years 5 mL to 10 m children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
FOR AGES 6-11 YEARS
Children's Allergy Relief
Diphenhydramine HCl 12.5 mg - Antihistamine
CHERRY FLAVOR
Compare to Children's Benadryl® Allergy active ingredient*
- Relief of: Runny nose, sneezing, itching of the nose or throat & itchy, watery eyes
- Alcohol free
- Dosing cup included
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Children's Benadryl® Allergy.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
- Product Label
-
INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-025 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) POLOXAMER 407 (UNII: TUF2IVW3M2) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SUCROSE (UNII: C151H8M554) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color Score Shape Size Flavor CHERRY (Cherry Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-025-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/03/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/03/2009 Labeler - Safeway, Inc. (009137209)
