253e5ced-7c45-4c31-8d1c-49cbbbfcf31f — v1

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Version

v1

Effective date

June 2, 2009

Original packager

Sections captured

16

Identifiers

Document ID
253e5ced-7c45-4c31-8d1c-49cbbbfcf31f
Set ID
253e5ced-7c45-4c31-8d1c-49cbbbfcf31f
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

Brand names
Generic names
Manufacturer names
Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Ask Doctor (1)

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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
Ask Doctor Or Pharmacist (1)

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Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout or arthritis
Do Not Use (1)

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Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer
Dosage And Administration (1)

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Directions drink a full glass of water with each dose do not exceed recommended dosage 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: ask a doctor
Inactive Ingredient (1)

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Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, edible ink, FD&C yellow #6, hypromellose, iron oxide black, methacrylic acid copolymer, microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Indications And Usage (1)

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Uses for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product
Keep Out Of Reach Of Children (1)

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Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

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Principal Display Panel Compare to Bayer® 81 mg Aspirin active ingredient Aspirin Low Dose Pain Reliever (NSAID) Safety Coated 81 mg See New Warnings Information This Package for Households Without Young Children {Non-CRC package only} Aspirin Carton Aspirin Carton
Pregnancy Or Breast Feeding (1)

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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 (1)

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Purpose Pain reliever
Questions (1)

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Questions? 1-800-719-9260
Spl Product Data Elements (1)

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Sunmark aspirin low dose Aspirin ASPIRIN ASPIRIN L535
Stop Use (1)

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Stop use and ask a doctor if 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 any new symptoms appear ringing in the ears or loss of hearing occurs
Storage And Handling (1)

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Other information {Non-CRC Package Only} store at 20°-25°C (68°-77°F)
Warnings (1)

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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 asthma (wheezing) shock Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer 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 Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout or arthritis Stop use and ask a doctor if 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 any new symptoms appear ringing in the ears or loss of hearing occurs 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.