SPL v2
SPL
SPL Set ID 2553d0cb-3f5c-7ea0-e063-6294a90a3cd4
Route
ORAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Propylene Glycol Polyethylene Glycol, Unspecified Hypromellose, Unspecified Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: 44;157;ASPIRIN Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1996-02-10

Description

Aspirin 325 mg (NSAID)* *nonsteroidal 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:

shock

facial swelling

hives

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

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you have asthma

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

gout

diabetes

arthritis

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.

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

ringing in the ears or a loss of hearing occurs

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

These could be signs of a serious condition.

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 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.

Indications and Usage

temporarily relieves: headache - pain and fever of colds - toothache - menstrual pain - muscle pain - minor pain of arthritis

Dosage and Administration

do not take more than directed

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 unless directed by a doctor

children under 12 years: do not use unless directed by a doctor

Description

Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Uses

temporarily relieves:

headache

pain and fever of colds

toothache

menstrual pain

muscle pain

minor pain of arthritis

Section 34084-4

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.

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

ringing in the ears or a loss of hearing occurs

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

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

an allergic reaction occurs. Seek medical help right away.

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

ringing in the ears or a loss of hearing occurs

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout

diabetes

arthritis

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 asthma

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

you are taking a diuretic

Section 51727-6

corn starch, hypromellose, polyethylene glycol, propylene glycol

Section 51945-4

Section 53413-1

1-800-645-2158

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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1

Pain reliever/fever reduce

Section 55106-9

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8

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

see end flap for expiration date and lot number

Directions

do not take more than directed

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 unless directed by a doctor

children under 12 years: do not use unless directed by a doctor


Structured Label Content

Uses (USES)

temporarily relieves:

headache

pain and fever of colds

toothache

menstrual pain

muscle pain

minor pain of arthritis

Indications and Usage (34067-9)

temporarily relieves: headache - pain and fever of colds - toothache - menstrual pain - muscle pain - minor pain of arthritis

Dosage and Administration (34068-7)

do not take more than directed

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 unless directed by a doctor

children under 12 years: do not use unless directed by 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:

shock

facial swelling

hives

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

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you have asthma

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

gout

diabetes

arthritis

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.

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

ringing in the ears or a loss of hearing occurs

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

These could be signs of a serious condition.

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 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.

Section 34084-4 (34084-4)

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.

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

ringing in the ears or a loss of hearing occurs

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

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

an allergic reaction occurs. Seek medical help right away.

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

ringing in the ears or a loss of hearing occurs

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout

diabetes

arthritis

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 asthma

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

you are taking a diuretic

Section 51727-6 (51727-6)

corn starch, hypromellose, polyethylene glycol, propylene glycol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-645-2158

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 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)

Pain reliever/fever reduce

Section 55106-9 (55106-9)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

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

see end flap for expiration date and lot number

Directions (DIRECTIONS)

do not take more than directed

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 unless directed by a doctor

children under 12 years: do not use unless directed by a doctor


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)