drug facts

drug facts
SPL v2
SPL
SPL Set ID 50c157d7-ea12-4a55-82ba-4190bd1fd4c5
Route
oral
Published
Effective Date 2012-08-02
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 ferric oxide yellow methacrylic acid - ethyl acrylate copolymer (1:1) type a cellulose, microcrystalline polysorbate 80 dimethicone sodium hydroxide sodium lauryl sulfate talc titanium dioxide triethyl citrate

Identifiers & Packaging

Pill Appearance
Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
otc monograph final active Since 2011-05-24

Purpose

Pain reliever

Description

Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug


Medication Information

Warnings

Children and teenagers who have or are recovering from chicken pox or flulike Reyeʼs syndrome:

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.

Aspirin may cause a severe allergic reaction, which may include: Allergy alert:

■ hives ■ facial swelling ■ shock ■ asthma (wheezing)

This product contains an NSAID, which may cause severe stomach Stomach bleeding warning:

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

■ if you are allergic to aspirin or any other pain reliever/fever reducer Do not use

■ stomach bleeding warning applies to you Ask a doctor before use if

■ 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

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

■ you experience any of the following signs of stomach bleeding: Stop use and ask a doctor if

■ 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

■ ringing in the ears or a loss of hearing occurs

, ask a health professional before use. It is especially important not If pregnant or breast-feeding

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.

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

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: consult a doctor

Other Information

■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

■ use by expiration date on package

**Compare to the active ingredient in Low Dose BAYER®

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered

trademark Bayer® Low Dose.

Distributed by

Major Pharmaceuticals

31778 Enterprise Drive,

Livonia, MI 48150 USA

  ASPIR LOW™

LOW STRENGTH 81mg ASPIRIN (NSAID)

Enteric Coated

1 1/4 gr. (81 mg) each Analgesic

SEE NEW WARNINGS INFORMATION

NEW Tablet Appearance

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

MAJOR®

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, triethyl citrate

Description

Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Questions?

Adverse Drug Event Call: (800) 616-2471

Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Aspir Low (aspirin) Tablet
Keep Out of Reach of Children

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


Structured Label Content

Warnings

Children and teenagers who have or are recovering from chicken pox or flulike Reyeʼs syndrome:

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.

Aspirin may cause a severe allergic reaction, which may include: Allergy alert:

■ hives ■ facial swelling ■ shock ■ asthma (wheezing)

This product contains an NSAID, which may cause severe stomach Stomach bleeding warning:

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

■ if you are allergic to aspirin or any other pain reliever/fever reducer Do not use

■ stomach bleeding warning applies to you Ask a doctor before use if

■ 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

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

■ you experience any of the following signs of stomach bleeding: Stop use and ask a doctor if

■ 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

■ ringing in the ears or a loss of hearing occurs

, ask a health professional before use. It is especially important not If pregnant or breast-feeding

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.

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

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: consult a doctor

Other Information

■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

■ use by expiration date on package

**Compare to the active ingredient in Low Dose BAYER®

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered

trademark Bayer® Low Dose.

Distributed by

Major Pharmaceuticals

31778 Enterprise Drive,

Livonia, MI 48150 USA

  ASPIR LOW™

LOW STRENGTH 81mg ASPIRIN (NSAID)

Enteric Coated

1 1/4 gr. (81 mg) each Analgesic

SEE NEW WARNINGS INFORMATION

NEW Tablet Appearance

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

MAJOR®

Inactive Ingredients (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, triethyl citrate

Questions?

Adverse Drug Event Call: (800) 616-2471

Active Ingredient (Active ingredient)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Aspir Low (aspirin) Tablet (ASPIR LOW (ASPIRIN) TABLET)
Keep Out of Reach of Children

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


Advanced Ingredient Data


Raw Label Data

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