Aspirin 325mg

Aspirin 325mg
SPL v3
SPL
SPL Set ID f2e7332a-bcd6-4aef-9e4c-a2cef5ea9464
Route
ORAL
Published
Effective Date 2012-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Starch, Corn Povidone

Identifiers & Packaging

Pill Appearance
Imprint: AP;010 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2002-01-09

Description

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

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

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

Uses

temporarily relieves

  • headache
  • menstrual pain
  • minor pain or arthritis
  • muscle pain
  • toothache
  • pain and fever and cold
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 signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

  • hives
  • asthma (wheezing)
  • shock
  • facial swelling

    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 (ibuprofen, naproxen, or others)
  • takes more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product.

    Do not use

  • if you have ever had an allergic reaction to any other pain reliever / fever reducer

    Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, lever cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

    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

    Stop use and ask a doctor if

  • you experiences 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 more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • 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.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and older : 1-2 tablets every 4 hours while symptoms last, but not more than 12 tablets in 24 hours.
  • Children under 12 years: ask a doctor
Active Ingredient

(in each tablet)

Aspirin 325 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Other Information
  • avoid excessive heat or humidity
  • store at 15-30 °C (59-86 °F)
Inactive Ingredients

corn starch, PVP

Questions Or Comments

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

For temporary relief of minor aches and pains

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel

NDC: 17714-010-01 – 100 Tablets

NDC: 17714-010-03  - 300 Tablets


Structured Label Content

Uses

temporarily relieves

  • headache
  • menstrual pain
  • minor pain or arthritis
  • muscle pain
  • toothache
  • pain and fever and cold
Purpose

Pain Reliever

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 signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

  • hives
  • asthma (wheezing)
  • shock
  • facial swelling

    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 (ibuprofen, naproxen, or others)
  • takes more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product.

    Do not use

  • if you have ever had an allergic reaction to any other pain reliever / fever reducer

    Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, lever cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

    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

    Stop use and ask a doctor if

  • you experiences 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 more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • 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.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and older : 1-2 tablets every 4 hours while symptoms last, but not more than 12 tablets in 24 hours.
  • Children under 12 years: ask a doctor
Active Ingredient

(in each tablet)

Aspirin 325 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Other Information
  • avoid excessive heat or humidity
  • store at 15-30 °C (59-86 °F)
Inactive Ingredients

corn starch, PVP

Questions Or Comments (Questions or Comments)

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

For temporary relief of minor aches and pains

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC: 17714-010-01 – 100 Tablets

NDC: 17714-010-03  - 300 Tablets


Advanced Ingredient Data


Raw Label Data

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