CHILDRENS ACETAMINOPHEN- acetaminophen suspension 
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.

----------

Drug Facts

Active Ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Acetaminophen.............................Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product

• do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
These could be signs of a serious condition.

Keep out of the reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical even if you do not notice any signs or
symptoms.

Directions

• this product does not contain directions or complete warnings for adult use.
• shake well before using

• mL = milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed by a doctor

Weight (lb.)                     Age (yrs.)                     Dose (mL*)
under 24                          under 2                      ask a doctor
24-35                                 2-3                             5 mL
36-47                                 4-5                             7.5 mL
48-59                                 6-8                             10 mL
60-71                                 9-10                           12.5 mL
72-95                                 11                              15 mL

* always check with your doctor before administering medicine to your infant/child

Other information

Inactive Ingredients

butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red #40, flavor, glycerin, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, xanthan gum

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 Tylenol®*
Children's Pain Relief
Suspension Liquid
Cherry Flavor
For ages 2 to 11
2 FL OZ (60 mL)

image of label

CHILDRENS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-041-011 in 1 CARTON08/17/2016
160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/17/2016
Labeler - We Care Distributors Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
PURINE PHARMA LLC019950491manufacture(70005-041)

Revised: 8/2016
Document Id: 813fae05-a5b9-40a6-83fa-5146a2625445
Set id: d073053e-5789-4bce-9246-cac0ada63c31
Version: 2
Effective Time: 20160817
 
We Care Distributors Inc.