Bayer description, usages, side effects, indications, overdosage, supplying and lots more!

Bayer

Bayer Corporation Consumer Care Division

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
BAYER ASPIRIN

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each powder pouch)

Aspirin 500 mg (NSAID)nonsterodial anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves

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

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
  • asthma (wheezing)
  • facial swelling
  • shock

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 (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

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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, liver 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

  • gout
  • diabetes
  • arthritis

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
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever lasts more than 3 days
  • new symptoms occur
  • 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.

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

Directions

  • adults and children 12 years and over: take contents of 1 powder pouch every 4 hours. Dissolve powder on tongue, followed by a full glass of water. Do not exceed 8 powder pouches in 24 hours.
  • children under 12 years: consult a doctor

Other information

  • Phenylketonurics: Contains Phenylalanine 5.6 mg Per Powder Pouch
  • save carton for full directions and warnings
  • store at room temperature

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, flavor, isomalt

Questions or comments?

1-800-331-4536 (Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com

PRINCIPAL DISPLAY PANEL - 500 mg Pouch Carton

See new warings information

NEW!

Aspirin (NSAID) Pain Reliever/Fever Reducer

BAYER ®

EXTRA STRENGTH

FAST RELEASE
POWDER

Dissolves Quickly
on your Tongue for
FAST PAIN RELIEF

citrus burst

10 SINGLE DOSE
POUCHES

PRINCIPAL DISPLAY PANEL - 500 mg Pouch Carton

Bayer

Aspirin POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0280-2500
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 500 mg

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0280-2500-10 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-06-30


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