drug facts

drug facts
SPL v1
SPL
SPL Set ID a03d1d10-1aa3-40cf-97f3-16c86596e9c3
Route
oral
Published
Effective Date 2011-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (81 mg)
Inactive Ingredients
anhydrous lactose carnauba wax silicon dioxide croscarmellose sodium d&c yellow no. 10 ferric oxide yellow methacrylic acid cellulose, microcrystalline polysorbate 80 dimethicone sodium hydroxide sodium lauryl sulfate talc titanium dioxide triethyl citrate

Identifiers & Packaging

Pill Appearance
Imprint: embossed;upper;8;lower;plain Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
otc monograph final active Since 2011-01-18
Description

Active ingredient (in each tablet)                   Purpose 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
  • 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

Active Ingredient
Active ingredient (in each tablet)                   Purpose

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

*nonsteroidal anti-inflammatory drug

Indications and Usage
Uses

  • for the temporarily 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 of this product

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

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

Section 44425-7
  • store between 20° - 25°C (60° - 77°F) in a dry place
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:
  • an allergic reaction occurs, Seek medical help right away.
  • 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
These could be signs of a serious condition.
Section 50568-5
Ask a doctor or pharmacist before use if you are
  • taking a prescription drug for:
  • gout, or arthritis

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

Section 50570-1
Do not use
  • if you are allergic to aspirin or any other pain reliever/fever reducer

Section 51727-6

Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, 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

Structured Label Content

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
  • 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

Active Ingredient (55106-9)
Active ingredient (in each tablet)                   Purpose

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

*nonsteroidal anti-inflammatory drug

Indications and Usage (34067-9)
Uses

  • for the temporarily 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 of this product

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; do not exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor
Section 44425-7 (44425-7)
  • store between 20° - 25°C (60° - 77°F) in a dry place
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:
  • an allergic reaction occurs, Seek medical help right away.
  • 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
These could be signs of a serious condition.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
  • taking a prescription drug for:
  • gout, or arthritis

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

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)

Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, 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)

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:12.155113 · Updated: 2026-03-14T22:52:34.752454