SPL v1
SPL
SPL Set ID 606067bb-b07f-444e-9465-d1e187735f3a
Route
ORAL
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Lactose Cellulose, Microcrystalline Polysorbate 80 Sodium Hydroxide Talc Titanium Dioxide Triethyl Citrate Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: A1 Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

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

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

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

Uses
  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headache or other symptoms needing immediate relief.
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
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
Do Not Use
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Questions?

Call toll free 1-800-630-8895

Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

Acrycoat, Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow# 10, Lactose, Microcrystalline Cellulose, Polysorbate 80, Sodium Hydroxide, Talc, Titanium Dioxide, Triethyl Citrate, Yellow Oxide of Iron.

Principal Display Panel

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
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 more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Aspirin 81mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for:

  • gout
  • diabetes
  • arthritis

Structured Label Content

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

Pain Reliever

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
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
Do Not Use (Do not use)
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Questions?

Call toll free 1-800-630-8895

Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

Acrycoat, Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow# 10, Lactose, Microcrystalline Cellulose, Polysorbate 80, Sodium Hydroxide, Talc, Titanium Dioxide, Triethyl Citrate, Yellow Oxide of Iron.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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 more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Aspirin 81mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for:

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)