ACETAMINOPHEN

FREDS, INC

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purposes
• ACETAMINOPHEN Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• ACETAMINOPHEN Other information
• Inactive ingredients
• Questions?
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FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purposes

Pain Reliever/Fever Reducer

ACETAMINOPHEN Uses

• for the temporary relief of minor aches and pains due to:

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
 

• more than 4,000 mg of acetaminophen in 24 hours
• 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.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product
  

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

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 the 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.

Directions

• take 2 caplets every 6 hours while symptoms last
• do not take more than 6 caplets in 24 hours unless directed by a doctor
• do not take more than 10 days unless directed by a doctor

Children under 12 years: ask a doctor

ACETAMINOPHEN Other information

• Store at room temperature
  

Inactive ingredients

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

Questions?

If you have any questions or comments, or to report an adverse event, please contact (888) 876-6898.

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