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DRUG FACTS


OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)                  Purpose

Aspirin 325 mg (NSAID*).............................Pain reliever

*nonsteroidal anti-inflammatory drug


OTC - PURPOSE SECTION

Pain reliever


INDICATIONS & USAGE SECTION

  • for the temporary relief of minor aches and pains due to
  • headachecoldsmuscle painmenstrual paintoothacheminor pain of arthritis
  • or as directed by your doctor

WARNINGS SECTION

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Aspirin may cause a severe allergic reaction, which may inclue:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin or any other pain reliever/fever reducer

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
  • you have not been drinking fluids

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drugs
  • under a doctor's care for any serious condition

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
  • feel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION


OTC - KEEP OUT OF REACH OF CHILDREN SECTION


DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION


OTC - QUESTIONS SECTION


Repackaging Information

Please reference the Product Characteristics section listed below for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:Cookeville, TN 3850620130604AW

Count325mg
3067544-468-30