387r Asa

387r Asa
SPL v3
SPL
SPL Set ID 5aaf8b66-b00e-4bc8-972c-bbe6825284fb
Route
ORAL
Published
Effective Date 2010-07-20
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 Cellulose, Microcrystalline 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


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 reaction which may include: hives, facial swelling, shock, asthma(wheezing

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 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

Description

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

Section 50565-1
eep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

K

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 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, you have not been drinking fluids, you have lost a lot of fluid due to vomiting or diarrhea
Section 50570-1
Do not use if you are allergic to aspirin or any other pain reliever/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, titanium dioxide

Section 51945-4

Enter section text here

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


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 reaction which may include: hives, facial swelling, shock, asthma(wheezing

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

K

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 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, you have not been drinking fluids, you have lost a lot of fluid due to vomiting or diarrhea
Section 50570-1 (50570-1)
Do not use if you are allergic to aspirin or any other pain reliever/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, titanium dioxide

Section 51945-4 (51945-4)

Enter section text here

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)