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ASPIRIN ENTERIC COATED - aspirin tablet, delayed release 
Western Family Foods Inc

Western Family Aspirin 81 mg Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product

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 a nonsteroidal anti-inflammatory drug (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

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

  • 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

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.

Directions

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

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, edible ink, FD&C yellow #6, hypromellose, iron oxide black, methacrylic acid copolymer, microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

See New Warnings Information

Enteric Coated

Aspirin 81 mg

Pain Reliever (NSAID)

Adult Low Strength 81 mg

Compare to Bayer® 81 mg Aspirin active ingredient

 81 mg Each

Aspirin 81 mg Carton

Aspirin 81 mg Carton


ASPIRIN  ENTERIC COATED
aspirin  tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 55312-535
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code L535
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 55312-535-76 1 BOTTLE In 1 CARTON contains a BOTTLE
1 120 TABLET In 1 BOTTLE This package is contained within the CARTON (55312-535-76)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 07/09/2022

Labeler - Western Family Foods Inc (192166072)
Revised: 06/2009Western Family Foods Inc