Heb Aspirin 325 Mg Tablets

Heb Aspirin 325 Mg Tablets
SPL v2
SPL
SPL Set ID 085b35db-62e4-38db-e063-6394a90a9763
Route
ORAL
Published
Effective Date 2014-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: TCL011 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

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

Indications and Usage

Uses for the temporary relief of minor aches and pains due to headache colds menstrual pain muscle pain toothache minor pain of arthritis or as directed by your doctor


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
  • shock
  • 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
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Indications and Usage

Uses

for the temporary relief of minor aches and pains due to

  • headache
  • colds
  • menstrual pain
  • muscle pain
  • toothache
  • minor pain of arthritis

or as directed by your doctor

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 while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • 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.

Section 50566-9

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

  • feel faint
  • have bloody or black stools
  • vomit blood
  • 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 in the painfull area

any new symptoms appear

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 diabetes, gout, or arthritis
  • taking any other drug
  • under a doctor's care for any serious condition
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
  • you have not been drinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea
Section 50570-1

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
Section 51727-6

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

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 casue problems in the unborn child or complications during delivery.

Section 55105-1

Purpose

Pain reliever

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
Principal Display Panel


Structured Label Content

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 while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • 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
  • shock
  • 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
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

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:

  • feel faint
  • have bloody or black stools
  • vomit blood
  • 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 in the painfull area

any new symptoms appear

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 diabetes, gout, or arthritis
  • taking any other drug
  • under a doctor's care for any serious condition
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
  • you have not been drinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea
Section 50570-1 (50570-1)

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
Section 51727-6 (51727-6)

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

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 casue problems in the unborn child or complications during delivery.

Section 55105-1 (55105-1)

Purpose

Pain reliever

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
Indications and Usage (INDICATIONS AND USAGE)

Uses

for the temporary relief of minor aches and pains due to

  • headache
  • colds
  • menstrual pain
  • muscle pain
  • toothache
  • minor pain of arthritis

or as directed by your doctor

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


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