Aspirin

Aspirin
SPL v2
SPL
SPL Set ID a1c73edf-861d-478b-9d3c-0eddcc6879cc
Route
ORAL
Published
Effective Date 2024-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Aspirin (NSAID)* 325mg (*non-steroidal anti-inflammatory drug)

Purpose

Pain Reliever/Fever Reducer


Medication Information

Purpose

Pain Reliever/Fever Reducer

Dosage and Administration

Directions:

Do not take more than directed.

Adults and children 12 years of age and over:

  • take 1 or 2 tablets with water every 4 hours while symptoms persist
  • do not take more than 12 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

Description

Aspirin (NSAID)* 325mg (*non-steroidal anti-inflammatory drug)

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • backache
  • muscular aches
  • minor arthritis pain
  • 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. 1-800-222-1222

Section 50566-9
  • an allergic reaction occurs, seek medical help right away
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • ringing in the ears or loss of hearing occurs
  • new symptoms occur
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

Section 50568-5
Ask a doctor or pharmacist before use if you:
  • take any other drug containing an NSAID
  • take a blood thinning (anticoagulant) or steroid drug
  • take any drug for diabetes, gout, or 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 are taking a diuretic
  • you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease
Section 50570-1

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Section 51727-6

Inactive Ingredients: corn starch, hypromellose,  polyethylene glycol, propylene glycol

Section 51945-4

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

Warnings

Reye's Syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin

Allergy altert: Aspirin may cause a several 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 ulers or bleeding problems
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, others)
  • have 3 or more alcholic drinks every day while using this product

Active Ingredient

Aspirin (NSAID)* 325mg (*non-steroidal anti-inflammatory drug)


Structured Label Content

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • backache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothache
  • menstrual cramps

Temporarily reduces fever

Dosage and Administration (34068-7)

Directions:

Do not take more than directed.

Adults and children 12 years of age and over:

  • take 1 or 2 tablets with water every 4 hours while symptoms persist
  • do not take more than 12 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask 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. 1-800-222-1222

Section 50566-9 (50566-9)
  • an allergic reaction occurs, seek medical help right away
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • ringing in the ears or loss of hearing occurs
  • new symptoms occur
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you:
  • take any other drug containing an NSAID
  • take a blood thinning (anticoagulant) or steroid drug
  • take any drug for diabetes, gout, or 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 are taking a diuretic
  • you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease
Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Section 51727-6 (51727-6)

Inactive Ingredients: corn starch, hypromellose,  polyethylene glycol, propylene glycol

Section 51945-4 (51945-4)

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

Purpose

Pain Reliever/Fever Reducer

Warnings

Reye's Syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin

Allergy altert: Aspirin may cause a several 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 ulers or bleeding problems
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, others)
  • have 3 or more alcholic drinks every day while using this product

Active Ingredient

Aspirin (NSAID)* 325mg (*non-steroidal anti-inflammatory drug)


Advanced Ingredient Data


Raw Label Data

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