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Drug Facts


Active Ingredient (in each caplet)

Acetaminophen 500 mg


Purpose

Pain Reliever/Fever Reducer


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

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 non prescription). 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children


OVERDOSAGE SECTION

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

Do not take more than directed

Adults and children 12 years and over:

Children under 12 years: do not use 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.

  • take 2 caplets every 4 to 6 hours while symptoms last
  • do not take more than 8 caplets in 24 hours
  • Do not take for more than 10 days unless directed by a doctor

Other information

  • Do not use if imprinted safety seal under cap is broken or missing.
  • store at room temperature

Inactive ingredients

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


Questions?

Adverse Drug Events call (800) 616-2471

Repacked by:

H.J. Harkins Company, Inc.

513 Sandydale Drive

Nipomo, CA 93444