Aspirin EC

Tablets, 81 mg · Aphena Pharma Solutions - Tennessee, LLC

Dosage Form

Tablets, 81 mg

Manufacturer

Aphena Pharma Solutions - Tennessee, LLC

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

temporarily relieves minor aches and pains
for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: consult a doctor

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

67544-524-30
67544-524-60

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

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 and 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 include:

hives
facial swelling
shock
asthma (wheezing)

Stomach bleeding warning

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

SPL UNCLASSIFIED SECTION

Repackaged by Aphena Pharma Solutions - TN.
See Repackaging Information for available configurations.

[image: mmAphena]

Distributed by: GOLDLINE LABORATORIES, INC., Sellersville, PA 18960

Dist. 1993 0711REV 89 387R

TAMPER-EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING

** This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer^® Low Dose.

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	81mg
30	67544-524-30
90	67544-524-60

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:
[image: mmAphena]
Cookeville, TN 38506

20130605AW

Sign up for full access

Create a free account to view complete drug information, save medications, and more.

Full drug information and details

Save medications to your personal list

Track your medication history

Get personalized drug safety alerts

Create Free Account Sign In

Free forever · No credit card required

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

How to take itDosage and administration instructions.

Do not use if…Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Ask a doctor before use if…Stop use and ask a doctor if 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…

Ask a doctor or pharmacist before use if…Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug under a doctor's care for any serious condition

Stop use and talk to a doctor if…if you are allergic to aspirin or any other pain reliever/fever reducer

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

Package labelNDC 67544-524 - Aspirin 81mg

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

Reye's syndrome

Allergy alert

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

Repackaging Information

Sign up for full access