381r Asa 81 Dr Tabs

381r Asa 81 Dr Tabs
SPL v2
SPL
SPL Set ID 9cb0c2df-5e72-42c5-ae93-144201fd263c
Route
ORAL
Published
Effective Date 2010-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Croscarmellose Ferric Oxide Yellow Propylene Glycol Shellac Talc Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Sodium Hydroxide Dimethicone Silicon Dioxide Sodium Lauryl Sulfate Starch, Corn Titanium Dioxide Triethyl Citrate Polysorbate 80 Anhydrous Lactose Ferrosoferric Oxide Brown Iron Oxide D&c Yellow No. 10 Hypromelloses Microcrystalline Cellulose Mineral Oil Potassium Hydroxide

Identifiers & Packaging

Pill Appearance
Imprint: T81 Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-08-10
Description

Active ingredient (in each tablet) Aspirin 81 mg (NSAID*)................................Pain reliever *nonsteroidal anti-inflammatory drug

Medication Information

Warnings and Precautions
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
  • shock
  • asthma (wheezing)

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
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Indications and Usage

Uses

  • 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

Dosage and Administration

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 not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Description

Active ingredient (in each tablet) Aspirin 81 mg (NSAID*)................................Pain reliever *nonsteroidal anti-inflammatory drug

Section 44425-7
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
Section 50565-1

Keep out of reach of children.

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

Section 50566-9
Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
  • feel faint
    • have bloody or black stools
    • vomit blood
    • 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

Section 50568-5

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

Section 50569-3

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
  • you have not been drinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea

Section 50570-1

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer

Section 51727-6
anhydrous lactose, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose sodium, d&C yellow #10 aluminum lake,hypromellose, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, Polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

Section 51945-4

Section 53414-9

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.

Section 55105-1

Purpose: Pain Reliever

Section 55106-9

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*)................................Pain reliever



*nonsteroidal anti-inflammatory drug

Structured Label Content

Indications and Usage (34067-9)

Uses

  • 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

Dosage and Administration (34068-7)

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 not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Warnings and Precautions (34071-1)
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
  • shock
  • asthma (wheezing)

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
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Section 44425-7 (44425-7)
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)
Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
  • feel faint
    • have bloody or black stools
    • vomit blood
    • 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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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
  • you have not been drinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea

Section 50570-1 (50570-1)

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer

Section 51727-6 (51727-6)
anhydrous lactose, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose sodium, d&C yellow #10 aluminum lake,hypromellose, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, Polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose: Pain Reliever

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*)................................Pain reliever



*nonsteroidal anti-inflammatory drug

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:42.590567 · Updated: 2026-03-14T22:55:22.018235