SPL v2
SPL
SPL Set ID 21517f45-f44c-6c4c-e063-6394a90a7a15
Route
ORAL
Published
Effective Date 2024-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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

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 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, 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 Breastfeeding, 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 deliver.

Keep out of reach of Children. In case of overdose, get medical help or contact a poison control center right away.

Do not use more than directed - the smallest effective dosage should be used. Drink a full glass of water with each dose. Do not take longer than 10 days, unless directed by a doctor.

Indications and Usage

Pain Reliever/Fever Reducer

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, skin reddening, facial swelling, rash, asthma (wheezing), blisters or 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 chance 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 problem, take more for a longer time than directed.

Dosage and Administration

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

Dosage Forms and Strengths

1 (2 Pack) 325 MG Packet

Description

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

Use

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. 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, you feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, 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.

Section 50567-7

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, skin reddening, facial swelling, rash, asthma (wheezing), blisters or 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 chance 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 problem, take more for a longer time than directed.

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 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, 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 Breastfeeding, 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 deliver.

Keep out of reach of Children. In case of overdose, get medical help or contact a poison control center right away.

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 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.

Section 50570-1

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.

Section 51727-6

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

MINERAL OIL (UNII: T5L8T28FGP)

HYPROMELLOSES (UNII: 3NXW29V3WO)

STARCH, CORN (UNII: O8232NY3SJ)

Section 51945-4

Section 53414-9

If pregnant or Breastfeeding, 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 deliver.

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 dosage 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 than 12 tablets in 24 hours or as directed as 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.


Structured Label Content

Use (USE)

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)

Pain Reliever/Fever Reducer

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, skin reddening, facial swelling, rash, asthma (wheezing), blisters or 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 chance 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 problem, take more for a longer time than directed.

Dosage and Administration (34068-7)

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

Dosage Forms and Strengths (34069-5)

1 (2 Pack) 325 MG Packet

Warnings and Precautions (34071-1)

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 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, 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 Breastfeeding, 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 deliver.

Keep out of reach of Children. In case of overdose, get medical help or contact a poison control center right away.

Do not use more than directed - the smallest effective dosage should be used. Drink a full glass of water with each dose. Do not take longer than 10 days, unless directed by a doctor.

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, you feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, 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.

Section 50567-7 (50567-7)

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, skin reddening, facial swelling, rash, asthma (wheezing), blisters or 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 chance 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 problem, take more for a longer time than directed.

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 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, 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 Breastfeeding, 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 deliver.

Keep out of reach of Children. In case of overdose, get medical help or contact a poison control center right away.

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 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.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

MINERAL OIL (UNII: T5L8T28FGP)

HYPROMELLOSES (UNII: 3NXW29V3WO)

STARCH, CORN (UNII: O8232NY3SJ)

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or Breastfeeding, 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 deliver.

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 dosage 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 than 12 tablets in 24 hours or as directed as 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.


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