Label: ALLERGY CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid
- NDC Code(s): 55910-091-04
- Packager: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- 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 October 24, 2022
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
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Ask a doctor before use if the child has
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium-restricted diet
-
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 mL 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
Children's
Allergy
DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
ORAL SOLUTION ANTIHISTAMINE
Relief of
- Itchy, water eyes
- Itchy throat
- Sneezing
- Runny nose
ALCOHOL FREE
Bubble Gum FLAVOR
FOR AGES 6-11
Dosing Cup included
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
PACKAGED FOR DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072 USA
Visit us at: Rexall.com
- Product Label
-
INGREDIENTS AND APPEARANCE
ALLERGY CHILDRENS ALLERGY
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-091 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 BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-091-04 1 in 1 BOX 06/30/2015 01/31/2025 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/30/2015 01/31/2025 Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)