CHILDRENS ACETAMINOPHEN LIQUID- acetaminophen liquid 
We Care Distributor 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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Children's Acetaminophen Elixir

Active Ingredient: Acetaminophen 160 mg (in each 5 mL)

Purpose: Pain reliever/fever reducer

Uses

temporarily:

Warnings:

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

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

  • with any other drug containing acetaminophen (prescription or non-prescription). if you are not sure wheather a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

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 or 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 for more than 5 days
  • fever gets worse or lasts for more than 3 days

These could be signs of a serious condition.

Keep out of reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.

Directions

Weight (lb.)        Age (yrs.)      Dose (mL)*

Under 24             Under 2         Ask a doctor

24-35                    2-3                 5mL

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

citric acid, FD&C red no. 40, flavor, glycerin, PEG 400, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

QUESTIONS & COMMENTS

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

Compare to the active ingredient in Children's Tylenol®*
Children's Acetaminophen Elixir
Cherry Flavor
For ages 2 to 11
2 FL OZ (60 mL)

This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®.

Children Acetaminophen Elixir - Cherry

CHILDRENS ACETAMINOPHEN LIQUID 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-048
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (cherry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-048-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/11/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
PURINE PHARMA LLC019950491manufacture(70005-048)

Revised: 10/2016
Document Id: 40bc5371-feeb-4620-8e7d-5c8e165d5257
Set id: b23302bd-170e-46ec-8f4f-524c378fa405
Version: 2
Effective Time: 20161012
 
We Care Distributor Inc.