FDA Label for Aspirin

Other

Drug Facts

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

Active Ingredient (In Each Tablet)

Aspirin 81 mg (NSAID

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• temporarily relieves minor aches and pains

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
• asthma (wheezing)
• shock

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

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

• gout
• diabetes
• arthritis

Stop Use And Ask A Doctor If

• an allergic reaction occurs. Seek medical help right away.
• you experience 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 for more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

  These could be signs of a serious condition.

  
  

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

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

Other Information

• store between 20°-25°C (68°-77°F) in a dry place
• retain carton for complete product information

Inactive Ingredients

acetylated monoglycerides, anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, hypromellose phthalate, iron oxide yellow, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polyethylene glycol, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Principal Display Panel - 180 Tablet Bottle Carton

RESTORE u

NDC 57344-146-01

^†COMPARE TO THE ACTIVE
INGREDIENT IN ST JOSEPH^®
SAFETY COATED ASPIRIN

ADULT
LOW DOSE

Safety
Coated

Aspirin
Pain Reliever
(NSAID)

81^mg

180 ENTERIC COATED TABLETS - 81 mg each