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Name:Allergychildrens
Manufacturer:Meijer Distribution Inc
Category:Over-the-counter (OTC) Marketed Drugs


Meijer Distribution, Inc. Children's Allergy Liquid Drug Facts

ALLERGY CHILDRENS - diphenhydramine hydrochloride liquid 
Meijer Distribution Inc

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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Meijer Distribution, Inc. Children's Allergy Liquid Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • if needed, take every 4-6 hours
  • do not take more than 6 doses in 24 hours

children under 4

years of age
do not use

children 4 to under 6

years of age
do not use unless directed by a doctor

children 6 to under

12 years of age

1 to 2 teaspoonfuls

(12.5 mg to 25 mg)

adults and children 12 years of age and over

2 to 4 teaspoonfuls

(25 mg to 50 mg)

Other information

  • each teaspoonful contains: sodium 15 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children’s Benadryl® Allergy Liquid active ingredient

Children’s

Allergy Liquid

Diphenhydramine HCl Oral Solution

Antihistamine

For Allergy Relief

Sneezing

Runny Nose

Itchy Throat

Itchy, Watery Eyes

Alcohol Free

Cherry Flavored

Children's

Children's Allergy Liquid Carton Image #1

Children's Allergy Liquid Carton Image #1

Children's Allergy Liquid Carton Image #2

Children's Allergy Liquid Carton Image #2


ALLERGY  CHILDRENS
diphenhydramine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-379
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 MONOHYDRATE  
D&C RED NO. 33  
FD&C RED NO. 40  
GLYCERIN  
HIGH FRUCTOSE CORN SYRUP  
POLOXAMER 407  
WATER  
SODIUM BENZOATE  
SODIUM CHLORIDE  
SODIUM CITRATE  
SORBITOL  
Product Characteristics
Color RED (Bluish-Red) Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41250-379-26 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (41250-379-26)
2 NDC:41250-379-34 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 236 mL in 1 BOTTLE This package is contained within the CARTON (41250-379-34)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/15/1987

Labeler - Meijer Distribution Inc (006959555)

Revised: 07/2009 Meijer Distribution Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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