SPL v1
SPL
SPL Set ID 13e621dc-b2b4-98fd-e063-6394a90acc75
Route
ORAL
Published
Effective Date 2024-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Stearic Acid Silicon Dioxide Dextrose Monohydrate Starch, Corn Fd&c Yellow No. 6 Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Imprint: PH034 Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-27

Description

Aspirin 81mg (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

hives

facial swelling

asthma (wheezing)

shock

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

for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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 have asthma

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

pain gets worse or lasts more than 10 days

fever get worse or lasts more than 3 days

redness or swelling is present

ringing in the ears or loss of hearing occurs

any new symptoms occur

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 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.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Indications and Usage

for the temporary relief of minor aches and pains or as recommneded by your doctor

ask your doctor about other uses for Chewable Aspirin 81 mg

Dosage and Administration

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 exceed 48 tablets in 24 hours unless directed by a doctor

children under 12 years consult a doctor

Description

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

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

ask your doctor about other uses for Chewable Aspirin 81 mg

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid

Section 51945-4

Section 53413-1

1-800-616-2471

Section 55105-1

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 exceed 48 tablets in 24 hours unless directed by a doctor

children under 12 years consult a doctor

Other Information

store at room temperature (150-300C)

Tamper Evident: do not use if safety seal under cap is broken or missing

Active Ingredient [in Each Tablet]

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


Structured Label Content

Uses (USES)

for the temporary relief of minor aches and pains or as recommended by your doctor

ask your doctor about other uses for Chewable Aspirin 81 mg

Indications and Usage (34067-9)

for the temporary relief of minor aches and pains or as recommneded by your doctor

ask your doctor about other uses for Chewable Aspirin 81 mg

Dosage and Administration (34068-7)

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 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

asthma (wheezing)

shock

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

for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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 have asthma

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

pain gets worse or lasts more than 10 days

fever get worse or lasts more than 3 days

redness or swelling is present

ringing in the ears or loss of hearing occurs

any new symptoms occur

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 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.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-616-2471

Section 55105-1 (55105-1)

Pain reliever

Directions (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 exceed 48 tablets in 24 hours unless directed by a doctor

children under 12 years consult a doctor

Other Information (OTHER INFORMATION)

store at room temperature (150-300C)

Tamper Evident: do not use if safety seal under cap is broken or missing

Active Ingredient [in Each Tablet] (ACTIVE INGREDIENT [IN EACH TABLET])

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)