Adult Low Dose Aspirin Delayed Release Tablets, 81 Mg

Adult Low Dose Aspirin Delayed Release Tablets, 81 Mg
SPL v2
SPL
SPL Set ID ad0d6a5c-eee9-406c-8d7f-1df9b45f5340
Route
ORAL
Published
Effective Date 2025-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Starch, Corn Povidone Microcrystalline Cellulose Croscarmellose Sodium Stearic Acid Silicon Dioxide Methacrylic Acid And Ethyl Acrylate Copolymer Triethyl Citrate Talc Titanium Dioxide D&c Yellow No. 10 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: A1 Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-12-01 Until 2028-06-30

Description

Drug Facts


Medication Information

Description

Drug Facts

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 headaches or symptoms needing immediate relief.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever

Section 55106-9

Active ingredients (in each tablet)

Aspirin 81 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

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

Distributed By:

Advanced Rx LLC

1942 NE 163ST,

North Miami Beach, FL 33162 U.S.A.

Other Information
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-68°F).
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients

Starch, Povidone, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and ethyl acrylate co-polymer, Triethyl Citrate, Talc, Fumed Silica, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6.

Principal Display Panel

NDC 80513-289-03

*Compare to the active ingredients in Bayer ®Aspirin Low Dose

Adult Low Dose Pain Reliever Aspirin Delayed Release Tablets, 81 mg

Pain Reliever (NSAID)

300 Enteric Coated Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Bayer ®

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
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 for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
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 headaches or symptoms needing immediate relief.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Aspirin 81 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

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

Distributed By: (Distributed by:)

Advanced Rx LLC

1942 NE 163ST,

North Miami Beach, FL 33162 U.S.A.

Other Information (Other information)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-68°F).
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients (Inactive ingredients)

Starch, Povidone, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and ethyl acrylate co-polymer, Triethyl Citrate, Talc, Fumed Silica, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 80513-289-03

*Compare to the active ingredients in Bayer ®Aspirin Low Dose

Adult Low Dose Pain Reliever Aspirin Delayed Release Tablets, 81 mg

Pain Reliever (NSAID)

300 Enteric Coated Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Bayer ®

Stomach Bleeding Warning: (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
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 for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
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

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