physicians care aspirin

physicians care aspirin
SPL v12
SPL
SPL Set ID aa67ea3a-2741-7ee0-e053-2a95a90a6485
Route
oral
Published
Effective Date 2022-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (325 mg)
Inactive Ingredients
starch, corn cellulose, microcrystalline povidone polyethylene glycol, unspecified hypromellose, unspecified propylene glycol

Identifiers & Packaging

Pill Appearance
Imprint: Aspirin;44;157 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
otc monograph drug completed Since 2020-07-20 Until 2023-05-31

Description

Drug Facts


Medication Information

Warnings and Precautions

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

■ shock

■ asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

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 or more alcohol drinks every day while using this product

■ take more or for a longer time than directed

Active Ingredient

Active ingredient (in each tablet)

Aspirin (NSAID*) 325 mg

*nonsteroidal anti-inflammatory drug

Indications and Usage

Uses

Temporarily relieves:

■ headache

■ minor arthritis pain

■ pain & fever of colds

■ backache

■ menstrual cramps

■ toothache

■ muscle aches

Dosage and Administration

Directions

■ drink a full glass of water with each dose

Adults and children 12 years and over:

take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours

Children under 12 years:

consult a doctor

Description

Drug Facts

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.

Section 50566-9

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 more than 10 days

■ fever gets worse or lasts more than 3 days

■ if ringing in the ears or loss of hearing occurs

■ redness or swelling is present in the painful area

■ any new symptoms appear

■ an allergic reaction occurs. Seek medical help right away.

Section 50568-5

Ask a doctor or pharmacist before use if you are

■ taking prescription drugs for gout, diabetes or arthritis

Section 50569-3

Ask a doctor before use if

■ stomach bleeding warning applies to you

■ you have asthma

■ 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

Section 50570-1

Do not use

■ if you are allergic to aspirin or to any other pain reliever/fever reducer

Section 51727-6

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

Section 51945-4

90014

Physicians Care®

Aspirin

Pain Reliever and fever Reducer (NSAID)

Pull To Open

This Package for Households without Young Children.

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Aspirin (NSAID) 325 mg

100 Tablets (50 Packets, 2 tablets each)

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 60561-8

Other information

■ read all product information before using

■ store at room temperature

■ avoid excessive heat and humidity

■ do not use any opened or torn packets

Physicians Care Aspirin Label

90014

Physicians Care®

Aspirin

Pain Reliever and fever Reducer (NSAID)

Pull To Open

This Package for Households without Young Children.

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Aspirin (NSAID) 325 mg

100 Tablets (50 Packets, 2 tablets each)


Structured Label Content

Warnings and Precautions (34071-1)

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

■ shock

■ asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

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 or more alcohol drinks every day while using this product

■ take more or for a longer time than directed

Active Ingredient (55106-9)

Active ingredient (in each tablet)

Aspirin (NSAID*) 325 mg

*nonsteroidal anti-inflammatory drug

Indications and Usage (34067-9)

Uses

Temporarily relieves:

■ headache

■ minor arthritis pain

■ pain & fever of colds

■ backache

■ menstrual cramps

■ toothache

■ muscle aches

Dosage and Administration (34068-7)

Directions

■ drink a full glass of water with each dose

Adults and children 12 years and over:

take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours

Children under 12 years:

consult a 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.

Section 50566-9 (50566-9)

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 more than 10 days

■ fever gets worse or lasts more than 3 days

■ if ringing in the ears or loss of hearing occurs

■ redness or swelling is present in the painful area

■ any new symptoms appear

■ an allergic reaction occurs. Seek medical help right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

■ taking prescription drugs for gout, diabetes or arthritis

Section 50569-3 (50569-3)

Ask a doctor before use if

■ stomach bleeding warning applies to you

■ you have asthma

■ 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

Section 50570-1 (50570-1)

Do not use

■ if you are allergic to aspirin or to any other pain reliever/fever reducer

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

Section 51945-4 (51945-4)

90014

Physicians Care®

Aspirin

Pain Reliever and fever Reducer (NSAID)

Pull To Open

This Package for Households without Young Children.

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Aspirin (NSAID) 325 mg

100 Tablets (50 Packets, 2 tablets each)

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless specifically 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)

Purpose

Pain reliever/fever reducer

Section 60561-8 (60561-8)

Other information

■ read all product information before using

■ store at room temperature

■ avoid excessive heat and humidity

■ do not use any opened or torn packets

Physicians Care Aspirin Label

90014

Physicians Care®

Aspirin

Pain Reliever and fever Reducer (NSAID)

Pull To Open

This Package for Households without Young Children.

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Aspirin (NSAID) 325 mg

100 Tablets (50 Packets, 2 tablets each)


Advanced Ingredient Data


Raw Label Data

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