Sound Body 44-600a-delisted

Sound Body 44-600a-delisted
SPL v14
SPL
SPL Set ID dc084d2a-2897-4a7c-989e-4a2a59ec7dbe
Route
ORAL
Published
Effective Date 2025-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose, Unspecified Methacrylic Acid Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Shellac Silicon Dioxide Dimethicone Water Sodium Bicarbonate Sodium Lauryl Sulfate Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: L Shape: round Color: yellow Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-05-01 Until 2025-10-12

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 your doctor. Because of its delayed action, this product will not provide fast relief of headaches 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
  • shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older

  • take more or for a longer time than directed

  • have had stomach ulcers or bleeding problems

  • have 3 or more alcoholic drinks every day while using this product

  • take a blood thinning (anticoagulant) or steroid drug
Directions
  • do not take more than directed

  • 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: do not use unless directed by 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 
Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

1-800-426-9391 

Principal Display Panel

SoundBody™

†Compare to the active

ingredient in Bayer®

Low Dose Aspirin

NDC 50844-563-32

LOW DOSE

Aspirin

Pain Reliever (NSAID) 81 mg

Safety Coated

Aspirin Regimen**

Actual Size

120 ENTERIC COATED TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


**Talk to your doctor or other healthcare provider

before using this product for your heart.

†This product is not manufactured or distributed

by Bayer AG, owner of the registered trademark

Bayer® Low Dose Aspirin.

50844     REV0122D60032

Distributed by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

V#733000 ITEM#022760032

Sound Body 44-600A
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 have asthma
  • you are taking a diuretic

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:
    • vomit blood

    • have bloody or black stools
    • feel faint

    • have stomach pain that does not get better

  • ringing in the ears or a loss of hearing occurs

  • 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

These could be signs of a serious condition.

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 overdose, get medical help or contact a Poison Control Center 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 your doctor. Because of its delayed action, this product will not provide fast relief of headaches 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
  • shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older

  • take more or for a longer time than directed

  • have had stomach ulcers or bleeding problems

  • have 3 or more alcoholic drinks every day while using this product

  • take a blood thinning (anticoagulant) or steroid drug
Directions
  • do not take more than directed

  • 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: do not use unless directed by 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 
Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-800-426-9391 

Principal Display Panel

SoundBody™

†Compare to the active

ingredient in Bayer®

Low Dose Aspirin

NDC 50844-563-32

LOW DOSE

Aspirin

Pain Reliever (NSAID) 81 mg

Safety Coated

Aspirin Regimen**

Actual Size

120 ENTERIC COATED TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


**Talk to your doctor or other healthcare provider

before using this product for your heart.

†This product is not manufactured or distributed

by Bayer AG, owner of the registered trademark

Bayer® Low Dose Aspirin.

50844     REV0122D60032

Distributed by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

V#733000 ITEM#022760032

Sound Body 44-600A
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 have asthma
  • you are taking a diuretic

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:
    • vomit blood

    • have bloody or black stools
    • feel faint

    • have stomach pain that does not get better

  • ringing in the ears or a loss of hearing occurs

  • 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

These could be signs of a serious condition.

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 overdose, get medical help or contact a Poison Control Center 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

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