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Childrens Allergy by Rite Aid Corporation

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Rite Aid Corporation
NDC Code: 11822-1417

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

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

Principal Display Panel


CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1417
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:11822-1417-4118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/30/2009
Labeler - Rite Aid Corporation (014578892)

Revised: 06/2017
 
Rite Aid Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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