COUNTERACT PAIN - acetaminophen tablet, film coated 
Melaleuca, Inc.

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CounterAct Pain Content of Label

Active ingredient (in each caplet)
Acetaminophen 500 mg

Purpose
Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• • headache
  • the common cold
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• temporarily reduces fever
  

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
  

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 you have

• liver disease
  

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
  

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 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.

If pregnant or breast-feeding, ask a health professional before use.

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 or symptoms.

Directions

• do not take more than directed (see overdose warning)
• adults and children 12 years and older
• • take 2 caplets every 4 to 6 hours
  • do not take more than 8 caplets in 24 hours, which is the maximum daily amount
  • do not take for more than 10 days unless directed by a doctor
    
• children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
  

Other information

• store at controlled room temperature 15°-30°C (59°-86°F)
  

Inactive ingredients  castor oil, hypromellose, povidone, sodium starch glycolate*, starch, stearic acid
*may contain this ingredient

Questions or comments?
1-800-282-3000

COUNTERACT  PAIN acetaminophen   tablet, film coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54473-099 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg

Inactive Ingredients Ingredient Name Strength CASTOR OIL   HYPROMELLOSES   POVIDONE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STARCH, CORN   STEARIC ACID

Product Characteristics Color white (White) Score no score Shape CAPSULE (Capsule shaped) Size 18mm Flavor Imprint Code 44;175 Contains

Packaging # NDC Package Description Multilevel Packaging 1 54473-099-50 1 BOTTLE In 1 BOX contains a BOTTLE 1 50 TABLET In 1 BOTTLE This package is contained within the BOX (54473-099-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/14/2009	02/28/2011

Labeler - Melaleuca, Inc. (139760102)

Revised: 04/2011Melaleuca, Inc.