11r Target 11673-188 Aspirin 325mg

11r Target 11673-188 Aspirin 325mg
SPL v3
SPL
SPL Set ID e8c87ccb-8c0c-7830-e053-2995a90a88b7
Route
ORAL
Published
Effective Date 2025-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: TCL011 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-05

Description

Active ingredient (in each tablet) Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug


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

• 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

Indications and Usage

Uses

• temporarily relieves minor aches and pains due to:

o headache

o muscle pain

o toothache

o menstrual pain

o colds

o minor pain of arthritis

• temporarily reduces fever

Dosage and Administration

Directions

• drink a full glass of water with each dose

• adults and children 12 years and over: take 1 to 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

Active ingredient (in each tablet) Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
Section 50570-1

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
Section 51727-6

Inactive ingredients corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

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.

Section 55105-1

Purposes

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8

Other information

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

• use by expiration date on package


Structured Label Content

Indications and Usage (34067-9)

Uses

• temporarily relieves minor aches and pains due to:

o headache

o muscle pain

o toothache

o menstrual pain

o colds

o minor pain of arthritis

• temporarily reduces fever

Dosage and Administration (34068-7)

Directions

• drink a full glass of water with each dose

• adults and children 12 years and over: take 1 to 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

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

• 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

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 (1-800-222-1222).

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

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

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

• use by expiration date on package


Advanced Ingredient Data


Raw Label Data

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