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Aspirin

Western Family Foods Inc

Western Family Aspirin 81 mg Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Aspirin Uses

  • temporarily relieves minor aches and pains

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:

  • 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

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

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout or 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
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs

These could be signs of a serious condition

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. (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 while symptoms persist
  • do not exceed 48 tablets in 24 hours or as directed by a doctor
children under 12 years
  • do not use unless directed by a doctor

Aspirin Other information

store at 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, edible ink, FD&C red no. 3, FD&C red no. 40, FD&C yellow no. 6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, pregelatinized starch, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

See New Warnings Information

Protects Against Stomach Upset

Pain Reliever (NSAID)

Aspirin

Adult Low Strength

81 mg

Enteric Safety Coated

Compare to St.Joseph® active ingredient

Aspirin
Aspirin 81 mg Carton

Aspirin

Aspirin TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-277
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
carnauba wax
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C RED NO. 3
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
cellulose, microcrystalline
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
STEARIC ACID
talc
titanium dioxide
triacetin
TRIETHYL CITRATE

Product Characteristics

Color Size Imprint Code Shape
ORANGE (peach) 8 mm L277 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 180 in 1 BOTTLE
2 NDC:55312-277-48 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2004-05-19


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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