CHILDRENS ALLERGY  - diphenhydramine hydrochloride liquid 
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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.

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Active Ingredient

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

Warnings Do not use

• to make a child sleepy
• if you are on a sodium-restricted diet
• with any other product containing diphenhydramine,
including one applied topically.

Ask a doctor before use if you have

• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or
chronic bronchitis

Ask a doctor or pharmacist before use if you are

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 this and all drugs out of the reach of children.

In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.

Directions

• use only enclosed dosing cup designed for use with
this product. Do not use any other dosing device.
• take every 4 to 6 hours
• do not exceed 6 doses in a 24-hour period

age                                                           dose
children 6 years to under 12 years      1 to 2 teaspoonfuls (12.5 mg to 25 mg)
children 4 years to under 6 years        do not use unless directed by a doctor
children under 4 years                          do not use

Other information

• each teaspoon contains: sodium 6 mg
• store at controlled room temperature

Inactive ingredients

citric acid, flavors, glycerin, poloxamer 407, purified water, red 33, red 40,
sodium benzoate, sodium chloride, sodium citrate, and sugar

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Premier Value Children's Allergy

Compare to the active ingredient in Benadryl Allergy Liquid Medication

Diphenhydramine Hydrochloride Antihistamine
Cherry flavor
alcohol free
Relieves sneezing, runny nose, itchy watery eyes, itchy throat

4 fl oz (118mL)

image of label


CHILDRENS ALLERGY  
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-025
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
CITRIC ACID MONOHYDRATE 
Glycerin 
Poloxamer 407 
Water 
Sodium Benzoate 
Sodium Chloride 
Sodium Citrate 
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:68016-025-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/29/200902/27/2013
Labeler - Premier Value (101668460)
Registrant - Aaron Industries, Inc. (030119387)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries, Inc.030119387manufacture(68016-025), analysis(68016-025)

Revised: 02/2013
 
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