ENTERIC COATED ASPIRIN 325mg

Active Ingredient

(in each tablet)

Aspirin 325 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ Fever Reducer

Uses

temporarily relieves

• headache
• menstrual pain
• muscle pain
• toothache
• minor pain or arthritis
• pain and fever of colds

Warnings

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 signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

• hives
• asthma (wheezing)
• shock
• facial swelling 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
• takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
• takes more or for a longer time than directed
• have 3 or more alcoholic drinks every day while using this product. Do not use
• if you have ever had an allergic reaction to any other pain reliever / fever reducer Ask a doctor before use if
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, lever cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma 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 ask a doctor if
• you experiences any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools
• 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

• adults and children 12 years and over : 1-2 tablets every 4 hours while symptoms last, but not more than 12 tablets in 24 hours.
• Children under 12 years: ask a doctor

Other Information

• avoid excessive heat or humidity
• store at 15-30 °C (59-86 °F)

Inactive Ingredients

croscarmellose sodium, D&C Yellow #10 (Al-Lake), FD&C yellow #6 (Al-Lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, PVP,  sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. 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 3850620180218JH