ALLERGY CHILDRENS- diphenhydramine hydrochloride liquid 
We Care Distributors 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.

----------

We Care Allergy Drug Facts

Active ingredient (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

*5 mL = 1 teaspoon (tsp)

Purpose

Antihistamine

Uses

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

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

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

Principal Display Panel

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 Carton Image 1

ALLERGY  CHILDRENS
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-036
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorRED (Bluish-Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-036-011 in 1 CARTON06/21/2016
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
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/FEIBusiness Operations
Purine Pharma019950491manufacture(70005-036)

Revised: 8/2016
Document Id: 6b19bc87-765d-4821-86a3-c42c4faea4f1
Set id: 990a0153-5f4d-4d1e-afe1-bd854a730123
Version: 3
Effective Time: 20160816
 
We Care Distributors Inc.