SPL v1
SPL
SPL Set ID 1d4fbc45-ef89-45ab-bc6d-41f30b468ac7
Route
ORAL
Published
Effective Date 2025-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol Povidone Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: ASP325 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-12

Description

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

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

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

Uses

temporary relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
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
Directions
  • do not take more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years of age 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

    • do not use for more than 10 days 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 reliever/fever reducer
Other Information
  • store at controlled room temperature 25ºC (77ºF) execursion permitted between 15-30ºC (59-86ºF)
  • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Talc, Titanium Dioxide

Questions Or Comments?

Call toll free 1 844-832-1138

Monday through Friday 9AM - 5PM EST

Principal Display Panel

Ask A Doctor Before Use If
  • you have asthma
  • 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
Stop Use and Ask A Doctor If

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 for 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
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.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug or are under a doctor's care for any serious condition

Structured Label Content

Uses

temporary relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
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 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
Directions
  • do not take more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years of age 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

    • do not use for more than 10 days unless directed by a doctor
  • children under 12 years:do not use unless directed by a doctor
Do Not Use (Do not use)
  • if you are allergic to aspirin or any other pain reliever/fever reducer
Other Information (Other information)
  • store at controlled room temperature 25ºC (77ºF) execursion permitted between 15-30ºC (59-86ºF)
  • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Talc, Titanium Dioxide

Questions Or Comments? (Questions or comments?)

Call toll free 1 844-832-1138

Monday through Friday 9AM - 5PM EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Ask A Doctor Before Use If (Ask a doctor before use if)
  • you have asthma
  • 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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 for 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
If Pregnant Or Breast Feeding, (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.

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 (1-800-222-1222) right away. 

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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 diabetes, gout, or arthritis
  • taking any other drug or are under a doctor's care for any serious condition

Advanced Ingredient Data


Raw Label Data

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