geri care 44-249

geri care 44-249
SPL v5
SPL
SPL Set ID 9f9ecec5-d692-4a0b-bf90-50f50c0b611c
Route
oral
Published
Effective Date 2017-11-29
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: 10 mm Score: 1
Marketing Status
otc monograph not final active Since 1993-08-04

Purpose

Pain reliever/fever reducer

How Supplied

Product: 50090-1617 NDC: 50090-1617-8 100 TABLET in a BOTTLE NDC: 50090-1617-4 20 TABLET in a BOTTLE

Description

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


Medication Information

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:

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

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
  • 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
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
Active Ingredient

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Uses

temporarily relieves:

  • pain and fever of colds
  • headache
  • muscle pain
  • minor pain of arthritis
  • toothache
  • menstrual pain
Purpose

Pain reliever/fever reducer

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
  • children under 12 years: ask a doctor
Other Information
  • use by expiration date on package
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
How Supplied

Product: 50090-1617

NDC: 50090-1617-8 100 TABLET in a BOTTLE

NDC: 50090-1617-4 20 TABLET in a BOTTLE

Description

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

Aspirin
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
Inactive Ingredient

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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
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.
  • 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
  • new symptoms occur
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

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:

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

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
  • 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
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
Active Ingredient (Active ingredient (in each tablet))

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Uses

temporarily relieves:

  • pain and fever of colds
  • headache
  • muscle pain
  • minor pain of arthritis
  • toothache
  • menstrual pain
Purpose

Pain reliever/fever reducer

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
  • children under 12 years: ask a doctor
Other Information (Other information)
  • use by expiration date on package
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
How Supplied (HOW SUPPLIED)

Product: 50090-1617

NDC: 50090-1617-8 100 TABLET in a BOTTLE

NDC: 50090-1617-4 20 TABLET in a BOTTLE

Aspirin
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
Inactive Ingredient (Inactive ingredient)

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 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)
  • 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.
  • 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
  • new symptoms occur
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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