SPL v6
SPL
SPL Set ID f4743dca-8d91-4811-b229-5b6cb38cc884
Route
ORAL
Published
Effective Date 2018-09-21
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 D&c Yellow No. 10 Iron Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Microcrystalline Cellulose Dimethicone Polysorbate 80 Sodium Hydroxide Sodium Lauryl Sulfate Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: embossed;upper;heart;lower;plain Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-06-28

Description

Active Ingredient in Each tablet Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug

How Supplied

Product: 50090-2832 NDC: 50090-2832-0 1 TABLET, COATED in a BLISTER PACK / 33 in a BOX, UNIT-DOSE


Medication Information

Warnings and Precautions

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 reactino which may include: hives, facial swelling, shock, asthma(wheezingStomach bleeding warning:  This product contains an NSAID which may cause severe stomach bleeding.  The chance is higher if you: are age 60 or older, hae had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or non prescription 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.

Indications and Usage

Uses: temporarily relieves minor aches and pains: for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

Dosage and Administration

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 - consult a doctor

How Supplied

Product: 50090-2832

NDC: 50090-2832-0 1 TABLET, COATED in a BLISTER PACK / 33 in a BOX, UNIT-DOSE

Description

Active Ingredient in Each tablet Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug

Section 50565-1

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if: you experience any of the following signs of stomach bleeding: feel faint, have bloody or black stools, vomit blood, have stomach pain that does not get better, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, redness or swelling is present in the painful area, any new symptoms appear

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis; under a doctor's care for any serious condition; taking any other drug

Section 50569-3

Ask a doctor before use if: stomach bleeding waring 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, you have not been drinking fluids, hou have lost a lot of fluid due to vomiting or diarhea

Section 50570-1

Do not use if your are allergic to aspirin or any other pain relieiver/fever reducer

Section 51727-6



Inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, itianium dioxide

Section 53414-9

If pregnant or breast-feeding, ask a health profession 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.

Section 55105-1

Uses - temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Section 55106-9

Active Ingredient in Each tablet

Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug

Aspirin

Structured Label Content

Indications and Usage (34067-9)

Uses: temporarily relieves minor aches and pains: for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

Dosage and Administration (34068-7)

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 - consult a doctor

Warnings and Precautions (34071-1)

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 reactino which may include: hives, facial swelling, shock, asthma(wheezingStomach bleeding warning:  This product contains an NSAID which may cause severe stomach bleeding.  The chance is higher if you: are age 60 or older, hae had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or non prescription 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.

Section 50565-1 (50565-1)

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if: you experience any of the following signs of stomach bleeding: feel faint, have bloody or black stools, vomit blood, have stomach pain that does not get better, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, redness or swelling is present in the painful area, any new symptoms appear

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis; under a doctor's care for any serious condition; taking any other drug

Section 50569-3 (50569-3)

Ask a doctor before use if: stomach bleeding waring 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, you have not been drinking fluids, hou have lost a lot of fluid due to vomiting or diarhea

Section 50570-1 (50570-1)

Do not use if your are allergic to aspirin or any other pain relieiver/fever reducer

Section 51727-6 (51727-6)



Inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, itianium dioxide

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health profession 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.

Section 55105-1 (55105-1)

Uses - temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Section 55106-9 (55106-9)

Active Ingredient in Each tablet

Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug

Aspirin (aspirin)
How Supplied (HOW SUPPLIED)

Product: 50090-2832

NDC: 50090-2832-0 1 TABLET, COATED in a BLISTER PACK / 33 in a BOX, UNIT-DOSE


Advanced Ingredient Data


Raw Label Data

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