Children's Allergy

diphenhydramine hydrochloride

Dosage Form: oral liquid
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

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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 63941-025-04 118 mL In 1 BOTTLE, PLASTIC None

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: 04/2009Best Choice

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• Allergic Reactions
• Cold Symptoms
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• Extrapyramidal Reaction
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