Aspirin 325mg (nsaid)

Aspirin 325mg (nsaid)
SPL v2
SPL
SPL Set ID 227cefca-acc4-41d0-e063-6394a90a35b9
Route
ORAL
Published
Effective Date 2024-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Starch, Corn Hypromellose, Unspecified Propylene Glycol Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 44157 Shape: round Color: white Size: 10 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-24

Description

Aspirin 325mg (NSAID) Nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever / Fever Reducer


Medication Information

Purpose

Pain Reliever / Fever Reducer

Description

Aspirin 325mg (NSAID) Nonsteroidal anti-inflammatory drug

Uses

Temporarily relieves:

Headache

Pain and fever of colds

toothache

menstrual pain

muscle pain

minor pain of arthritis

Label

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 behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a reare but serious illness.

Allergy Alert

Aspirin may cause severe allergic reaction, which may include, facial swelling, hives, shock, asthma (wheezing).

Stomach bleeding warning

This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you

  • Have had stomach ulcers or bleeding problems
  • Take blood thinning (anticogulant) or steroid drug
  • Are age 60 or older
  • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others)
  • Take more or for a longer time than directed
  • Have 3 or more alcoholic drinks every day while using this product

Directions

Do not take more than directed. See overdose warning

Drink a full glass of water with each dose

Adults and children 12 years and older

  • Take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor.

Children under 12 years

  • Do not use unless directed by a doctor
Do Not Use
  • If you are allergic to aspirin or any other pain releiver / fever reducer
  • If you have ever had an allergic reaction to this product or any of its ingredients
Distributed By:

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

*This product is not manufactured or distributed by the Bayer Healthcare LLC. owner of the registered trademark Bayer®

Reorder No. 2023

Made in the USA

Active Ingredient

Aspirin 325mg (NSAID)

Nonsteroidal anti-inflammatory drug

Other Information
  • Store at 25ºC (77ºF)
  • Excursions permitted between 15ºC-30ºC (59ºF-86ºF)
  • See end flap for expiration date and lot number
  • Use by expiration date on package
Inactive Ingredients

Corn Starch, Hyperomelose, Polyethylene glycol, propylene glycol

Questions Or Comments?

Call 1-888-296-9067

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

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 stools, have stomach pain that does not get better
  • Ringing in the ears or loss of hearing occurs, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days.
  • New symptoms occur,
  • Redness or swelling is present
  • Thse 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 at 20 weeks or later in 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 overdose, get medical help or contact a poison control center right away.

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for gout, diabetes, arthritis


Structured Label Content

Uses

Temporarily relieves:

Headache

Pain and fever of colds

toothache

menstrual pain

muscle pain

minor pain of arthritis

Label

Purpose

Pain Reliever / Fever Reducer

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 behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a reare but serious illness.

Allergy Alert

Aspirin may cause severe allergic reaction, which may include, facial swelling, hives, shock, asthma (wheezing).

Stomach bleeding warning

This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you

  • Have had stomach ulcers or bleeding problems
  • Take blood thinning (anticogulant) or steroid drug
  • Are age 60 or older
  • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others)
  • Take more or for a longer time than directed
  • Have 3 or more alcoholic drinks every day while using this product

Directions

Do not take more than directed. See overdose warning

Drink a full glass of water with each dose

Adults and children 12 years and older

  • Take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor.

Children under 12 years

  • Do not use unless directed by a doctor
Do Not Use
  • If you are allergic to aspirin or any other pain releiver / fever reducer
  • If you have ever had an allergic reaction to this product or any of its ingredients
Distributed By:

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

*This product is not manufactured or distributed by the Bayer Healthcare LLC. owner of the registered trademark Bayer®

Reorder No. 2023

Made in the USA

Active Ingredient

Aspirin 325mg (NSAID)

Nonsteroidal anti-inflammatory drug

Other Information
  • Store at 25ºC (77ºF)
  • Excursions permitted between 15ºC-30ºC (59ºF-86ºF)
  • See end flap for expiration date and lot number
  • Use by expiration date on package
Inactive Ingredients

Corn Starch, Hyperomelose, Polyethylene glycol, propylene glycol

Questions Or Comments? (Questions or Comments?)

Call 1-888-296-9067

Ask A Doctor Before Use If (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

Stop Use and Ask A Doctor If (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 stools, have stomach pain that does not get better
  • Ringing in the ears or loss of hearing occurs, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days.
  • New symptoms occur,
  • Redness or swelling is present
  • Thse could be signs of a serious condition
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 (Keep out of reach of children)

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for gout, diabetes, arthritis


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