SPL v1
SPL
SPL Set ID 14d3399a-4c48-f2b3-e063-6394a90aeca9
Route
ORAL
Published
Effective Date 2024-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Mineral Oil Cellulose, Microcrystalline Croscarmellose Sodium Starch, Corn Hypromelloses Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL;011 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-12-30

Description

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


Medication Information

Warnings and Precautions

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of 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, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock. If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The change is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks everyday while using this product, take more for a longer time than directed

Indications and Usage

Do not use more than directed - the smallest effective dose should be used.

Drink a full glass of water with each dose.

Do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more then 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Avoid excessive heat and humidity, do not use any open or torn packets.

Dosage and Administration

Aspirin (NSAID*) 325mg

Do not use more than directed - the smallest effective dose should be used.

Drink a full glass of water with each dose.

Do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more then 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Avoid excessive heat and humidity, do not use any open or torn packets.

Description

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

Uses

Temporarily relieves minor aches and pains associated with: headache; muscular aches; minor arthritis pain; backache; common cold; toothache; menstrual cramps; temporarily reduces fever

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

MINERAL OIL

CELLULOSE, MICROCRYSTALLINE

CROSCARMELLOSE SODIUM

HYPROMELLOSES

TITANIUM DIOXIDE

STARCH, CORN

Section 51945-4

Section 55105-1

Pain Reliever / Fever Reducer

Section 55106-9

Aspirin (NSAID*) 325mg

*nonsteroidal anti-inflammatory drug

Directions

Do not use more than directed - the smallest effective dose should be used.

Drink a full glass of water with each dose.

Do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more then 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Avoid excessive heat and humidity, do not use any open or torn packets.

Do Not Use Aspirin

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis.

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.

Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug.

When using this product: Take with food or milk if stomach upset occurs.

Stop Use and Ask Doctor Aspirin

Stop Use and ask a Doctor if:

You experience any of the following signs of stomach bleeding, you 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, you have difficulty swallowing, if ringing in the ears or loss of hearing occurs, redness or swelling is present in painful areas, or any new symptoms appear.

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 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.


Structured Label Content

Uses (USES)

Temporarily relieves minor aches and pains associated with: headache; muscular aches; minor arthritis pain; backache; common cold; toothache; menstrual cramps; temporarily reduces fever

Indications and Usage (34067-9)

Do not use more than directed - the smallest effective dose should be used.

Drink a full glass of water with each dose.

Do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more then 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Avoid excessive heat and humidity, do not use any open or torn packets.

Dosage and Administration (34068-7)

Aspirin (NSAID*) 325mg

Do not use more than directed - the smallest effective dose should be used.

Drink a full glass of water with each dose.

Do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more then 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Avoid excessive heat and humidity, do not use any open or torn packets.

Warnings and Precautions (34071-1)

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of 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, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock. If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The change is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks everyday while using this product, take more for a longer time than directed

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

MINERAL OIL

CELLULOSE, MICROCRYSTALLINE

CROSCARMELLOSE SODIUM

HYPROMELLOSES

TITANIUM DIOXIDE

STARCH, CORN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain Reliever / Fever Reducer

Section 55106-9 (55106-9)

Aspirin (NSAID*) 325mg

*nonsteroidal anti-inflammatory drug

Directions (DIRECTIONS)

Do not use more than directed - the smallest effective dose should be used.

Drink a full glass of water with each dose.

Do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more then 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Avoid excessive heat and humidity, do not use any open or torn packets.

Do Not Use Aspirin (DO NOT USE- ASPIRIN)

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis.

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.

Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug.

When using this product: Take with food or milk if stomach upset occurs.

Stop Use and Ask Doctor Aspirin (STOP USE AND ASK DOCTOR- ASPIRIN)

Stop Use and ask a Doctor if:

You experience any of the following signs of stomach bleeding, you 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, you have difficulty swallowing, if ringing in the ears or loss of hearing occurs, redness or swelling is present in painful areas, or any new symptoms appear.

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 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.


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