1146-bst-2024-0613

1146-bst-2024-0613
SPL v4
SPL
SPL Set ID 6fa1c707-bd42-455b-90a3-2c2a11acc683
Route
ORAL
Published
Effective Date 2024-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Anhydrous Lactose Carnauba Wax Silicon Dioxide Croscarmellose Sodium Fd&c Red No. 40 Aluminum Oxide Fd&c Yellow No. 6 Ferric Oxide Yellow Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Cellulose, Microcrystalline Polysorbate 80 Dimethicone Sodium Hydroxide Sodium Lauryl Sulfate Talc Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: heart Shape: round Color: orange Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-05-01 Until 2028-06-30

Description

Drug Facts

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains
  • ask your doctor about other uses for this product
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 right away (1-800-222-1222).

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking a prescription drug for:

  • diabetes
  • gout
  • arthritis
Section 50570-1

Do not useif you are allergic to aspirin or any other pain reliever/fever reducer

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.

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: do not use unless directed by a doctor
Allergy Alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
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.

Other Information
  • store between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information and warnings
Inactive Ingredients

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrate

Questions Or Comments?

1-844-292-1112

Principal Display Panel

Best Choice®

Compare to the active ingredient in St.Jopseph® Low Dose Aspirin†

LOW DOSE

Aspirin 81 mg

PAIN RELIEVER (NSAID)

Aspirin Regimen**

Safety Coated

Talk to your doctor or other healthcare provider before using this product for your heart

Actual Size

81mg each

100 ENTERIC COATED TABLETS

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
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

These could be signs of a serious condition.

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID*)

* nonsteroidal anti-inflammatory drug


Structured Label Content

Uses
  • temporarily relieves minor aches and pains
  • ask your doctor about other uses for this product
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 right away (1-800-222-1222).

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking a prescription drug for:

  • diabetes
  • gout
  • arthritis
Section 50570-1 (50570-1)

Do not useif you are allergic to aspirin or any other pain reliever/fever reducer

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.

Purpose

Pain reliever

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: do not use unless directed by a doctor
Allergy Alert (Allergy alert)

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Reye's Syndrome (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.

Other Information (Other information)
  • store between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information and warnings
Inactive Ingredients (Inactive ingredients)

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-844-292-1112

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Best Choice®

Compare to the active ingredient in St.Jopseph® Low Dose Aspirin†

LOW DOSE

Aspirin 81 mg

PAIN RELIEVER (NSAID)

Aspirin Regimen**

Safety Coated

Talk to your doctor or other healthcare provider before using this product for your heart

Actual Size

81mg each

100 ENTERIC COATED TABLETS

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
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

These could be signs of a serious condition.

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

Aspirin 81 mg (NSAID*)

* nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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