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
| Count | 325mg |
| 30 | 67544-468-30 |