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Allergy Childrens by We Care Distributors Inc.

Medically reviewed on August 16, 2016

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: We Care Distributors Inc.
NDC Code: 70005-036

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.

We Care Allergy Drug Facts

Active ingredient (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

*5 mL = 1 teaspoon (tsp)

Purpose

Antihistamine

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

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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

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. (1-800-222-1222)

Directions
  • take every 4 - 6 hours
  • do not take more than 6 times in 24 hours

Age (yr)

Dose

Adult and children 12

years of age and over

10-20 mL

(25 to 50 mg)

Children 6 to under

12 years of age

5-10 mL

(12.5 to 25 mg)

Children under 6 years

of age

Ask a doctor

Other information
  • store at room temperature 15-30°C (59-86°F)
  • protect from freezing
  • protect from light
  • each teaspoon (5 mL) contains: sodium 16 mg

Inactive ingredients

citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium sacchrin, sorbitol, sucrose

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

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Compare to the active ingredient in Children’s Benadryl® Allergy Liquid

See New Warnings and Directions

CHILDREN'S ALLERGY

LIQUID MEDICATION

DIPHENHYDRAMINE HCl

ORAL SOLUTION

ANTIHISTAMINE

Relieves: Sneezing, Runny nose, Itchy, watery eyes, Itchy throat

Cherry Flavored

Alcohol Free

ALLERGY  CHILDRENS
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-036
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
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SACCHARIN SODIUM 
SUCROSE 
SORBITOL 
Product Characteristics
ColorRED (Bluish-Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70005-036-011 BOTTLE in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/21/2016
Labeler - We Care Distributors Inc. (079832998)
Establishment
NameAddressID/FEIOperations
Purine Pharma019950491manufacture(70005-036)

 
We Care Distributors Inc.

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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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