Aspirin 81mg Enteric Coated Tcb

Aspirin 81mg Enteric Coated Tcb
SPL v4
SPL
SPL Set ID a661a9ed-9b31-46b1-aafb-61d1ba8a4918
Route
ORAL
Published
Effective Date 2024-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Yellow No. 10 Lactose Monohydrate Methacrylic Acid Microcrystalline Cellulose 102 Polacrilin Potassium Polyvinyl Alcohol, Unspecified Polyethylene Glycol 6000 Talc Silicon Dioxide Sodium Lauryl Sulfate Soybean Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: round Color: yellow Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-31

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 or as recommended by a doctor.

    Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
  • ask your doctor about other uses for safety coated 81 mg aspirin












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 severs allergic reaction, which may include:

  • hives
  • shock
  • facial swelling
  • 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 longer time than directed
Directions
  • drink a full glass of water 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
Package Label
PUBLIX Low Dose Aspirin
Other Information
  • store between 15-30ºC (59-86ºF)
Inactive Ingredients

Croscarmellose sodium, D&C yellow #10, lactose monohydrate, methacrylic acid, microcrystalline cellulose 102, polacrilin potassium, polyethylene glycol 6000, polyvinyl alcohol, purfied talc, silicon dioxide, sodium lauryl sulphate, soybean, titanium dioxide, triethyl citrate

Principal Display Panel

Compare to the active ingredient in Bayer® Low Dose Aspirin†

LOW DOSE

aspirin

ASPIRIN REGIMEN 81 mg±

PAIN RELIEVER (NSAID)

  • Safety coated±±

TABLETS

†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin.

±Talk to your doctor or other healthcare provider before using this product for your hearth. Aspirin is not right for everyone.

±±Coating helps protect against stomach upset.

TAMPER EVIDENT: DO NOR USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY PUBLIX SUPERMARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY,

LAKELAND, FL 33811

Pregnancy/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.

Ask A Doctor Before Use If
  • stomach bleeding warning applies to you
  • you have 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
  • ringing in the ears or loss of hearing occurs
  • new symptoms occur

These could be a signs of a serious condition.

Keep Out of Reach of Children.

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

Active Ingredient(in Each Tablet)

Aspirin 81 mg (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 a doctor.

    Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
  • ask your doctor about other uses for safety coated 81 mg aspirin












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 severs allergic reaction, which may include:

  • hives
  • shock
  • facial swelling
  • 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 longer time than directed
Directions
  • drink a full glass of water 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
Package Label (Package label)
PUBLIX Low Dose Aspirin
Other Information (Other information)
  • store between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, D&C yellow #10, lactose monohydrate, methacrylic acid, microcrystalline cellulose 102, polacrilin potassium, polyethylene glycol 6000, polyvinyl alcohol, purfied talc, silicon dioxide, sodium lauryl sulphate, soybean, titanium dioxide, triethyl citrate

Principal Display Panel

Compare to the active ingredient in Bayer® Low Dose Aspirin†

LOW DOSE

aspirin

ASPIRIN REGIMEN 81 mg±

PAIN RELIEVER (NSAID)

  • Safety coated±±

TABLETS

†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin.

±Talk to your doctor or other healthcare provider before using this product for your hearth. Aspirin is not right for everyone.

±±Coating helps protect against stomach upset.

TAMPER EVIDENT: DO NOR USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY PUBLIX SUPERMARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY,

LAKELAND, FL 33811

Pregnancy/breast Feeding, (Pregnancy/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.

Ask A Doctor Before Use If (Ask a doctor before use if)
  • stomach bleeding warning applies to you
  • you have 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
  • ringing in the ears or loss of hearing occurs
  • new symptoms occur

These could be a signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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

Aspirin 81 mg (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)