328r Aspirin Low Dose

328r Aspirin Low Dose
SPL v2
SPL
SPL Set ID 55d645bb-8645-4984-a7b9-3e6eed8c6412
Route
ORAL
Published
Effective Date 2010-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Croscarmellose Ferric Oxide Yellow Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Polysorbate 80 Dimethicone Triethyl Citrate Silicon Dioxide Sodium Starch Glycolate Type A Corn Anhydrous Lactose Microcrystalline Cellulose Carnauba Wax Sodium Hydroxide Sodium Lauryl Sulfate Talc Fd&c Red No. 40 Food Yellow 3 Free Acid

Identifiers & Packaging

Pill Appearance
Imprint: emobssed;upper;heart;lower;plain Shape: round Color: white Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-08-11
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, CARNAUBA WAX, COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM, FD&C YELLOW#6 ALUMINUM LAKE, FD&C RED #40 ALUMINUM LAKE, IRON OXIDE OCHRE, METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER, MICROCRYSTALLINE CELLULOSE, POLYSORBATE 80, SIMETHICONE, SODIUM HYDROXIDE, SODIUM LAURYL SULFATE, TALC, 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, CARNAUBA WAX, COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM, FD&C YELLOW#6 ALUMINUM LAKE, FD&C RED #40 ALUMINUM LAKE, IRON OXIDE OCHRE, METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER, MICROCRYSTALLINE CELLULOSE, POLYSORBATE 80, SIMETHICONE, SODIUM HYDROXIDE, SODIUM LAURYL SULFATE, TALC, 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:42.613611 · Updated: 2026-03-14T22:55:22.018235