COUNTERACT CHILDRENS PAIN RELIEVER- acetaminophen suspension 
Melaleuca, 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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CounterAct Children's Pain Reliever Content of label

Active ingredient (in each 5 mL teaspoon)
Acetaminophen 160 mg

Purpose
Pain reliever/fever reducer

Use 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, or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

Stop use and ask a doctor if

These could be signs of a serious condition.

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) Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

Weight (lb)
Age (yr)
Dose (tsp or mL)
under 24
under 2 years
ask a doctor
24-35
2-3 years
1 tsp or 5 mL
36-47
4-5 years
1 1/2 tsp or 7.5 mL
48-59
6-8 years
2 tsp or 10 mL
60-71
9-10 years
2 1/2 tsp or 12.5 mL
72-95
11 years
3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device/

Other information

Inactive ingredients  anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, FD and C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellusose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Questions or comments?
1-800-282-3000

image of label

image of box
COUNTERACT  CHILDRENS PAIN RELIEVER
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-098
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)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred (Red) Score    
ShapeSize
FlavorCHERRY (cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-098-041 in 1 BOX
15 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/12/2010
Labeler - Melaleuca, Inc. (139760102)

Revised: 3/2011
Document Id: 0366e2e1-80fe-4980-839f-277ef17d9639
Set id: cc448c06-b682-4ae2-8aa6-a8ec59b37b1b
Version: 1
Effective Time: 20110316
 
Melaleuca, Inc.