Aspirin 325mg

Aspirin 325mg
SPL v1
SPL
SPL Set ID 93fb4359-c93d-46c4-b36e-611b829f514c
Route
ORAL
Published
Effective Date 2018-10-12
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 NOT FINAL Active Since 2018-10-11

Description

Pain Reliever/Fever Reducer (NSAID)

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Pain Reliever/Fever Reducer (NSAID)

Uses

temporarily relieves:

  • pain and fever of colds
  • toothache
  • headache
  • muscle pain
  • minor pain of arthritis
  • menstrual pain
Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis
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 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

  • 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]
  • are age 60 or older
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product
Directions
  • drink a full glass of water with each dose
  • adults and children 12 years and over: 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 reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Asprin 325 Mg

Pain Reliever/Fever Reducer

(NSAID)

Other Information
  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

corn starch, hypromellose, polyethylene glycol,

propylene glycol

Questions Or Comments?

1-800-736-3437

Ask A Doctor Before Use If
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have asthma
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
  • ringing in the ears or a loss of hearing occurs
  • 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

These could be signs of a serious condition.

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


Structured Label Content

Uses

temporarily relieves:

  • pain and fever of colds
  • toothache
  • headache
  • muscle pain
  • minor pain of arthritis
  • menstrual pain
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis
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 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

  • 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]
  • are age 60 or older
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product
Directions
  • drink a full glass of water with each dose
  • adults and children 12 years and over: 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 (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
Asprin 325 Mg (Asprin 325 mg)

Pain Reliever/Fever Reducer

(NSAID)

Other Information (Other information)
  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, polyethylene glycol,

propylene glycol

Questions Or Comments? (Questions or comments?)

1-800-736-3437

Ask A Doctor Before Use If (Ask a doctor before use if)
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have asthma
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 or black stools
  • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • 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

These could be signs of a serious condition.

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


Advanced Ingredient Data


Raw Label Data

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