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Bayer Fast Release

Dosage form: powder
Ingredients: Aspirin 500mg
Labeler: Bayer Corporation Consumer Care Division
NDC Code: 0280-2500

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

BAYER®
ASPIRIN

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

BAYER  FAST RELEASE
aspirin powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-2500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (Aspirin) Aspirin500 mg
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCITRUSImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-2500-1010 POWDER (POUCH) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2010
Labeler - Bayer Corporation Consumer Care Division (785159372)

Revised: 06/2010
 
Bayer Corporation Consumer Care Division

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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