Sig - 1081b - 2024-1125

Sig - 1081b - 2024-1125
SPL v3
SPL
SPL Set ID 96359eb6-62bc-4b13-960c-050af99a8c02
Route
ORAL
Published
Effective Date 2024-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose, Unspecified Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Cellulose, Microcrystalline Mineral Oil Polysorbate 80 Dimethicone Sodium Hydroxide Sodium Lauryl Sulfate Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: T Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-05

Description

Drug Facts

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Drug Facts

Uses
  • for the temporary relief of minor aches and pains due to:
    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • colds
    • minor pain of arthritis
  • or as recommended by your doctor
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 have ever had an allergic reaction to 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 1 to 2 tablets every 4 hours; do not exceed 12 tablets in 24 hours
  • children under 12 years: ask a doctor
Allergy Alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)
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
Inactive Ingredients

corn starch, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Principal Display Panel

COMPARE TO

Ecotrin® Regular Strength Aspirin

Active ingredient†

NDC 21130-081-05

Signature SELECT™

REGULAR STRENGTH

ENTERIC COATED

ASPIRIN 325mg

Pain Reliever (NSAID)

• Safety coated

Actual Size

500 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 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 325 mg (NSAID

nonsteroidal anti-inflammatory drug
)


Structured Label Content

Uses
  • for the temporary relief of minor aches and pains due to:
    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • colds
    • minor pain of arthritis
  • or as recommended by your doctor
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 have ever had an allergic reaction to 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 1 to 2 tablets every 4 hours; do not exceed 12 tablets in 24 hours
  • children under 12 years: ask a doctor
Allergy Alert (Allergy alert)

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)
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
Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO

Ecotrin® Regular Strength Aspirin

Active ingredient†

NDC 21130-081-05

Signature SELECT™

REGULAR STRENGTH

ENTERIC COATED

ASPIRIN 325mg

Pain Reliever (NSAID)

• Safety coated

Actual Size

500 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 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 325 mg (NSAID

nonsteroidal anti-inflammatory drug
)


Advanced Ingredient Data


Raw Label Data

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