CHILDRENS ACETAMINOPHEN ORAL SUSPENSION GRAPE FLAVOR- acetaminophen suspension 
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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Drug Facts

Active ingredient

(in each 5 mL)
Acetaminophen 160 mg

Purpose

Acetaminophen
160 mg.............................Pain reliever/fever reducer

Uses

temporarily

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 reach of children.

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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 or symptoms.

Directions

Weight (lb)   Age (yr)        Dose (tsp or 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

butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, D&C red # 33, FD&C blue # 1, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

QUESTIONS OR COMMENTS?

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

Principal Display Panel

Childrens Acetaminophen Oral Suspension

• Fever reducer
• Pain reliever

Alcohol Free
Aspirin Free
Ibuprofen Free

Grape Flavor

Compare to active ingredient in Childrens Tylenol Fever reducer Pain reliever

2 FL OZ (60 mL)

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CHILDRENS ACETAMINOPHEN ORAL SUSPENSION  GRAPE FLAVOR
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-040
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
SODIUM BENZOATE (UNII: OJ245FE5EU)  
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)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-040-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/26/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/26/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
PURINE PHARMA LLC019950491manufacture(70005-040)

Revised: 9/2016
Document Id: 4d3f87a4-cd9e-49a4-8b0b-464cbcc7673e
Set id: 0e8ed405-6c5f-4264-84a2-36af46632c33
Version: 2
Effective Time: 20160926
 
We Care Distributor Inc.