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Aspirin

Advance Pharmaceutical Inc.
Advance Pharmaceutical Inc.

ENTERIC COATED ASPIRIN 325mg




FULL PRESCRIBING INFORMATION

(in each tablet)

Aspirin 325 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Pain reliever

temporarily relieves

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

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.

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

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

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

Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Safer for your stomach than pain or Buffered Aspirin

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

AspirinAspirin

NDC: 17714-011-01 – 100 Tablets

Aspirin

Aspirin TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:17714-011
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 325 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
METHACRYLIC ACID
POLYETHYLENE GLYCOL 1000
propylene glycol
povidone
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
talc
titanium dioxide
HYPROMELLOSES

Product Characteristics

Color Size Imprint Code Shape
ORANGE 8 mm AP;011 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:17714-011-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1990-05-08


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Be sure to consult your doctor before taking any medication!
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