FDA Label for Counteract Pain

Otc - Active Ingredient

Active Ingredients (in each caplet)
Acetaminophen 500 mg

Otc - Purpose

Purposes
Pain Reliever/fever reducer

Indications & Usage

Uses

• for the temporary relief of 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

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
  

Otc - 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.

Otc - Ask Doctor

Ask a doctor before use if you have

• liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
  

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions

• do not take more than directed (see overdose warning)
• adults and children 12 years and over
• • take 2 caplets every 4 to 6 hours while symptoms last
  • do not take more than 8 caplets in 24 hours
  • do not take 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
    
  
  

Storage And Handling

Other information

• store at room temperature
  

Inactive Ingredient

Inactive ingredients  Hypromellose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Otc - Questions

Questions or comments?  If you have any questions or comments, or to report and adverse event, please contact 1-800-282-3000.

Boxed Warning

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Package Label.Principal Display Panel

Bottle - CounterActPainBottle 1115