1146-qch-2024-0613

1146-qch-2024-0613
SPL v2
SPL
SPL Set ID bfb9af64-3195-44bf-bcf3-6b36b40d3cc7
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 active Since 2024-05-01

Purpose

Pain reliever

Description

Drug Facts


Medication Information

Active Ingredient

Aspirin 81 mg (NSAID*)

* nonsteroidal anti-inflammatory drug

Uses
  • temporarily relieves minor aches and pains
  • ask your doctor about other uses for this product
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
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

Description

Drug Facts

Principal Display Panel

QUALITY CHOICE®

NDC 83324-090-36

** Compare to Active Ingredient in ST JOSEPH® Low Dose Aspirin

Low Dose

Aspirin 81 mg

Pain Reliever (NSAID)

Enteric Coated | Saftey Coated | Aspirin Regimen†

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

36 TABLETS

Actual Size

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.

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.

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.


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Aspirin 81 mg (NSAID*)

* nonsteroidal anti-inflammatory drug

Uses
  • temporarily relieves minor aches and pains
  • ask your doctor about other uses for this product
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
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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

QUALITY CHOICE®

NDC 83324-090-36

** Compare to Active Ingredient in ST JOSEPH® Low Dose Aspirin

Low Dose

Aspirin 81 mg

Pain Reliever (NSAID)

Enteric Coated | Saftey Coated | Aspirin Regimen†

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

36 TABLETS

Actual Size

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.

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.

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.


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