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Childrens Allergy by Safeway, Inc.

Medically reviewed on March 29, 2018

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Safeway, Inc.
NDC Code: 21130-025

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 Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

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

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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
  • each 5 mL contain: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • protect from light. Store in outer carton until contents are used

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40 flavor glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

 Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

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

www.betterlivingbrandsLLC.com

Product Label

SIGNATURE CARE Children's Allergy Relief

 

CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-025
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
TRISODIUM CITRATE DIHYDRATE 
SUCROSE 
D&C RED NO. 33 
FD&C RED NO. 40 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-025-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/03/2009
Labeler - Safeway, Inc. (009137209)

 
Safeway, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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