Aspirin 325mg

Aspirin 325mg
SPL v2
SPL
SPL Set ID 31e76aff-63f6-4ee6-8a48-80a73890e607
Route
ORAL
Published
Effective Date 2017-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AP;010 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-06-01

Description

Pain Reliever/ Fever Reducer


Medication Information

Description

Pain Reliever/ Fever Reducer

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 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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

Aspirin 325 Mg (nsaid) *

Pain Reliever/ Fever Reducer

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: 54738-541-01   ....Aspirin 325mg 100 tablets

NDC: 54738-541-02 ....Aspirin 325mg 500 tablets


Structured Label Content

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 (Questions or Comments)

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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

Aspirin 325 Mg (nsaid) * (Aspirin 325 mg (NSAID) *)

Pain Reliever/ Fever Reducer

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: 54738-541-01   ....Aspirin 325mg 100 tablets

NDC: 54738-541-02 ....Aspirin 325mg 500 tablets


Advanced Ingredient Data


Raw Label Data

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