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Aspirin

Rugby Laboratories Inc.
Advance Pharmaceutical Inc.

Aspirin Tablets (NSAID) * nonsteroidal anti-inflammatory drug




FULL PRESCRIBING INFORMATION

(in each tablet)

Aspirin 81 mg

Pain Reliever

  • 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.

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
  • facial swelling
  • asthma (wheezing)
  • shock

    Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding.

    The chances 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 non-prescription NSAIDs (ibuprofen, naproxen, or others)
  • take more or for 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 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

    Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout or arthritis
  • under a doctor’s care for any serious condition
  • taking any other drug

    Stop use and ask a doctor if

  • 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 more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any symptoms appear
  • ringing in the ears or 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 three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complication during delivery.

    Keep out of reach of children. 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 & older: take 4 or 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
  • children under 12 years: ask a doctor
  • store at room temperature 15°-30°C (59°-86°F)

croscarmellose sodium, D&C Yellow # 10 (AL-lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol/propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxide

Call 1-800-645-2158, 9am–5pm ET, Monday - Friday

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

  • Aspirin

Aspirin

NDC 0536-3086-41

Rugby

Enteric Coated

Aspirin 81 mg Tablets (NSAID)
Analgesic

120 Tablets

Aspirin

NDC 0536-3086-10

Rugby

Enteric Coated

Aspirin 81 mg Tablets (NSAID)
Analgesic

1000 Tablets

Aspirin

Aspirin TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-3086
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 81 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
HYPROMELLOSES
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
cellulose, microcrystalline
propylene glycol
POVIDONE K30
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
YELLOW 8 mm AP;121 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-3086-41 120 in 1 BOTTLE
2 NDC:0536-3086-10 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2008-04-28


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Be sure to consult your doctor before taking any medication!
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