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FDA LABEL GENERIC: Aspirin MFR: PLx Pharma Inc

Asa 81 Mg Oral Capsule [vazalore]

INDICATIONS AND USAGE

For temporary relief of minor aches and pains associated with: headache Backache muscular aches a cold toothache minor pains of arthritis premenstrual and menstrual cramps temporarily redices fever n ask your doctor about other uses of aspirin capsules

WARNINGS

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

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

n hives n facial wseelling n shock n astham (wheezing)

This product contains soy

Stomach bleeding warning: This product contains an NSAID, which may cause 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

Active Ingredient (in Each capsules)

Aspirin (NSAID)* 325mg

*Non steroidal Anti inflammatory Drug

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, liver cirrhosis, or kidney disease You are taking a diuretic You have asthma

Do not use If you have ever had an allergic reaction to aspirin or any other pain reliever / fever reducer

Ask a doctor or a pharmacist before you use if you are

Taking a drug for diabetes, gout or arthritis

Stop use and ask a doctor if

An allergic reaction occurs. Seek medical help right away You experience amu of the following signs of stomach bleeding

- Feel faint - vomit blood - have bloody or black stool - 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 Ringing in the ears or loss of hearing occurs Redness and swelling is present in the painful area Any new symptoms occur. These could be signs of serious conditions

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

If pregnant or breast feeding, ask a healthcare 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

Purposes:

Aspirin (NSAID)* 325mg __ Pain reliever / fever reducer

*Non steroidal Anti inflammatory Drug

Questions or comments?

Call 1-888-842-3569 9:00 AM – 7:00 PM ET, Monday – Friday

RETAIN CARTON FOR COMPLETE WARNINGS AND INFORMATION

Other Information

Save carton for full directions and warnings Store at 15-30°C (59-86°F) Avoid excessive heat above 40°C (104°F) Do not use if the blue band around the capsule is missing or broken

Inactive ingredients

Anhydrous citric acid, carrageenan, colloidal silicon dioxide, FD&C blue #1, Hypromellose, lecithin, oleic acid, pharmaceutical ink, potassium chloride, soybean oil, titanium dioxide

DOSAGE AND ADMINISTRATION

Directions

Drink a full glass of water with each dose Adults and children 12 years and over: Take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist Do not exceed 12 capsules in 24 hours Children under 12 years consult a doctor

30 Count Blister Carton

30 Count Bottle Label

4 Count Blister Card

4 Count Blister Carton

12 Count Blister Carton