Regular Strength Aspirin EC
Aphena Pharma Solutions - Tennessee, LLC
DRUG FACTS
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Active ingredient
Active ingredient (in each tablet) Purpose
Aspirin 325 mg (NSAID*).............................Pain reliever
*nonsteroidal anti-inflammatory drug
Purpose
PurposePain reliever
Uses
Uses- for the temporary relief of minor aches and pains due to
-
- headache
- colds
- muscle pain
- menstrual pain
- toothache
- minor pain of arthritis
- or as directed by your doctor
Reye's syndrome:
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.
Allergy alert:
Aspirin may cause a severe allergic reaction, which may inclue:
- hives
- facial swelling
- shock
- asthma (wheezing)
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- if you are allergic to aspirin or any other pain reliever/fever reducer
- 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
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drugs
- under a doctor's care for any serious condition
- you experience any of the following signs of stomach bleeding:
-
- feel faint
- have bloody or black stools
- vomit blood
- have 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
- 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
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
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:
| Count | 325mg |
| 30 | 67544-468-30 |
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 38506
20130604AW
PRINCIPAL DISPLAY PANEL - 325mg
NDC 67544-468 - Aspirin EC 325mg
Regular Strength Aspirin ECAspirin TABLET, DELAYED RELEASE
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