Compare To The Active Ingredient In Bayer®

Compare To The Active Ingredient In Bayer®
SPL v1
SPL
SPL Set ID 9105eff0-1c22-4298-8ee5-9fb7a1de12f1
Route
ORAL
Published
Effective Date 2026-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetylsalicylic Acid (81 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Ferric Oxide Yellow Lactose, Unspecified Form Methacrylic Acid And Ethyl Acrylate Copolymer Microcrystalline Cellulose Polysorbate 80 Sodium Hydroxide Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: 81 Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-09

Description

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


Medication Information

Description

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

Uses
  • temporary relief of minor aches and pains or as recommended by your doctor.

    Because of its delayed release action, this product will not provide fast relief of headache or symptoms needing immediate relief.
Section 50566-9

Stop use and ask a doctor if

  • you experience any of the following signs of stomach

    bleeding: 
  • feel faint
  • has bloody or black stools 
  • vomits blood
  • has stomach pain that does not get better 
  • an allergic reaction occurs. Seek medical help right away.
  • ringing in the ears or loss of hearing occurs 
  • pain gets worse or lasts for more than 10 days 
  • fever get worse or lasts for more than 3 days 
  • redness or swelling is present in the painful area
  • new symptoms appear. These could be sign of a serious condition.
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • under a doctor’s care for any serious condition
  • taking any other drug
Section 50569-3

Ask a doctor before use if 

  • You have asthma 
  • 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
Section 53413-1

Questions and comments? Call 1-844-474-7464

This product is not manufactured or distributed by Bayer, owner of the registered trademark Aspirin Regimen BAYER®

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/1362

Issued: 06/2025

S-063

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.

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
  • 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 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 while symptoms last
  • do not take more than 48 tablets in 24 hours unless directed by doctor
  • children under 12 years: ask a doctor

Other information

  • store at room temperature 15-30°C (59-86°F)
Do Not Use
  • if you are allergic to aspirin, or any other pain reliever/fever reducer
Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, D&C yellow 10, iron oxide yellow 6, lactose, methacrylic acid and ethyl acrylate copolymer,

microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Package Label.principal Display Panel
Do Not Use If Imprinted Safety Seal Under Cap Is Broken Or Missing.

Drug Facts

Active ingredient (in each tablet)                        Purpose

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

*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses
  • temporary relief of minor aches and pains or as recommended by your doctor.

    Because of its delayed release action, this product will not provide fast relief of headache or symptoms needing immediate relief.
Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you experience any of the following signs of stomach

    bleeding: 
  • feel faint
  • has bloody or black stools 
  • vomits blood
  • has stomach pain that does not get better 
  • an allergic reaction occurs. Seek medical help right away.
  • ringing in the ears or loss of hearing occurs 
  • pain gets worse or lasts for more than 10 days 
  • fever get worse or lasts for more than 3 days 
  • redness or swelling is present in the painful area
  • new symptoms appear. These could be sign of a serious condition.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • under a doctor’s care for any serious condition
  • taking any other drug
Section 50569-3 (50569-3)

Ask a doctor before use if 

  • You have asthma 
  • 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
Section 53413-1 (53413-1)

Questions and comments? Call 1-844-474-7464

This product is not manufactured or distributed by Bayer, owner of the registered trademark Aspirin Regimen BAYER®

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/1362

Issued: 06/2025

S-063

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.

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
  • 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 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 while symptoms last
  • do not take more than 48 tablets in 24 hours unless directed by doctor
  • children under 12 years: ask a doctor

Other information

  • store at room temperature 15-30°C (59-86°F)
Do Not Use (Do not use)
  • if you are allergic to aspirin, or any other pain reliever/fever reducer
Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, croscarmellose sodium, D&C yellow 10, iron oxide yellow 6, lactose, methacrylic acid and ethyl acrylate copolymer,

microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate

Keep Out of Reach of Children. (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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
Do Not Use If Imprinted Safety Seal Under Cap Is Broken Or Missing. (DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.)

Drug Facts

Active ingredient (in each tablet)                        Purpose

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

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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