Health Star 44-249

Health Star 44-249
SPL v2
SPL
SPL Set ID e55d7d98-ffe0-4a0f-a36c-6649ec093278
Route
ORAL
Published
Effective Date 2015-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;249 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1993-08-04

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

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • minor pain of arthritis
  • backache
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
Purposes

Pain reliever/fever reducer

Warnings

: 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. Reye's syndrome

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

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

: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: Stomach bleeding warning

  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
Directions
  • drink a full glass of water with each dose
  • adults and children 12 years 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
  • 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.

Aspirin Tablet
Active Ingredient

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

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

corn starch

Questions Or Comments?

1-800-540-3765

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 are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
Stop Use and Ask A Doctor If
  • 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
  • an allergic reaction occurs.  Seek medical help right away.
  • new symptoms occur
  • ringing in the ears or 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

These could be signs of a serious condition.

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.

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • minor pain of arthritis
  • backache
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
Purposes

Pain reliever/fever reducer

Warnings

: 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. Reye's syndrome

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

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

: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: Stomach bleeding warning

  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
Directions
  • drink a full glass of water with each dose
  • adults and children 12 years 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
  • 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.

Aspirin Tablet (ASPIRIN TABLET)
Active Ingredient (Active ingredient)

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

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

corn starch

Questions Or Comments? (Questions or comments?)

1-800-540-3765

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 are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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
  • an allergic reaction occurs.  Seek medical help right away.
  • new symptoms occur
  • ringing in the ears or 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

These could be signs of a serious condition.

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.

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

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

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