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Children's Allergy

Generic Name: diphenhydramine hydrochloride
Dosage Form: oral liquid

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

Diphenhydramine HCl 12.5 mg

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

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

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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Children's Allergy
Antihistamine
Liquid Medication
Relieves Sneezing, runny nose, itchy, watery eyes, itchy throat
Cherry flavored
alcohol free
antihistamine
Diphenhydramine HCI
4 fl oz 118mL

CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-025
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 12.5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid  
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     
Shape Size
Flavor CHERRY (Cherry Flavor) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:63941-025-04 118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/28/2009
Labeler - Best Choice (868703513)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
Name Address ID/FEI Operations
Aaron Industries, Inc. 101896231 manufacture, analysis
Revised: 04/2009
 
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