COUNTERACT CHILDRENS PAIN RELIEVER- acetaminophen suspension

CounterAct by

Drug Labeling and Warnings

CounterAct by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose
Pain reliever/fever reducer

INDICATIONS & USAGE

Use temporarily:

• reduces fever
• relieves minor aches and pains due to:
• • the common cold
  • flu
  • headache
  • sore throat
  • toothache
    

WARNINGS

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

DO NOT USE

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 DOCTOR

Ask a doctor before use if your child has liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

STOP USE

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

Directions

• do not give more than directed (see Liver warning)
• shake well before use
• find right dose on chart. 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.
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give for more than 5 days unless directed by a doctor
• this product does not contain directions or complete warnings for adult use

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/

STORAGE AND HANDLING

Other information

• store at 20°-25°C (68°-77°F)
  

GENERAL PRECAUTIONS

• each teaspoon contains: sodium 3 mg
• do not use if printed neckband is broken or missing
  

INACTIVE INGREDIENT

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

Questions or comments?
1-800-282-3000

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUNTERACT  CHILDRENS PAIN RELIEVER
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-098
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (Red)	Score
Shape		Size
Flavor	CHERRY (cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-098-04	1 in 1 BOX
1		5 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/12/2010

Labeler - Melaleuca, Inc. (139760102)