Childrens Allergy by Rite Aid Corporation Drug Facts

Childrens Allergy by

Drug Labeling and Warnings

Childrens Allergy by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid 
Rite Aid Corporation

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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-1417
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-1417-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/30/2009	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/30/2009	10/01/2019

Labeler - Rite Aid Corporation (014578892)

Revised: 9/2019

Document Id: 9d533936-da1d-4251-85ef-2dce3621cabf

34390-5

Set id: 8ccf5998-cc5a-40cf-bc98-f7004b3bb0f0

Version: 3

Effective Time: 20190927

 

Rite Aid Corporation