SPL v2
SPL
SPL Set ID 95c34d67-3a72-49d4-89aa-7186ac58c0dc
Route
ORAL
Published
Effective Date 2012-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Ferrosoferric Oxide Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromelloses Methacrylic Acid Cellulose, Microcrystalline Polydextrose Polyethylene Glycols Propylene Glycol Shellac Silicon Dioxide Dimethicone Sodium Bicarbonate Sodium Lauryl Sulfate Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: L Shape: round Color: yellow Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2000-07-01

Description

Aspirin 81 mg(NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Aspirin 81 mg(NSAID)* *nonsteroidal anti-inflammatory drug

Uses
  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin
Section 50565-1

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

Warnings

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: 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.

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. Reye's Syndrome:

Aspirin may cause a severe allergic reaction which may include: Allergy Alert:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Stomach bleeding warning:

  • 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

if your are allergic to aspirin or any other pain reliever/fever reducer. Do not use

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis  -kidney disease -asthma


Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug

  • 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
  • an allergic reaction occurs. Seek medical help right away
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present

  • fever gets worse or lasts more than 3 days
  • any new symptoms occur

  • ringing in the ears or loss of hearing occurs
If pregnant or breast-feeding,
Directions
  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush

  • do not exceed recommended dose
  • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor
Other Information
  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only
Inactive Ingredients

cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose, phthalate, lactose, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.

Active Ingredient (in Each Tablet)

Aspirin 81 mg(NSAID)* *nonsteroidal anti-inflammatory drug



Adult Low Dose Enteric Coated Aspirin (aspirin) Tablet, Coated

Structured Label Content

Uses
  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin
Section 50565-1 (50565-1)

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

Purpose

Pain reliever

Warnings

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: 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.

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. Reye's Syndrome:

Aspirin may cause a severe allergic reaction which may include: Allergy Alert:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Stomach bleeding warning:

  • 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

if your are allergic to aspirin or any other pain reliever/fever reducer. Do not use

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis  -kidney disease -asthma


Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug

  • 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
  • an allergic reaction occurs. Seek medical help right away
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present

  • fever gets worse or lasts more than 3 days
  • any new symptoms occur

  • ringing in the ears or loss of hearing occurs
If pregnant or breast-feeding,
Directions
  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush

  • do not exceed recommended dose
  • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor
Other Information (Other information)
  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only
Inactive Ingredients (Inactive ingredients)

cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose, phthalate, lactose, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81 mg(NSAID)* *nonsteroidal anti-inflammatory drug



Adult Low Dose Enteric Coated Aspirin (aspirin) Tablet, Coated (ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED)

Advanced Ingredient Data


Raw Label Data

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