Label: BAYER FAST RELEASE- aspirin powder
- NDC Code(s): 0280-2500-10
- Packager: Bayer Corporation Consumer Care Division
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated June 2, 2010
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each powder pouch)
Pain reliever/fever reducerClose
- pain and fever of colds
- minor pain of arthritis
- muscle pain
- menstrual pain
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.
Aspirin may cause a severe allergic reaction which may include:
- asthma (wheezing)
- 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 (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
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.
- 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, isomaltClose
- Questions or comments?
1-800-331-4536 (Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.comClose
- PRINCIPAL DISPLAY PANEL - 500 mg Pouch Carton
See new warings information
Aspirin (NSAID) Pain Reliever/Fever Reducer
on your Tongue for
FAST PAIN RELIEF
10 SINGLE DOSE
- INGREDIENTS AND APPEARANCE
BAYER FAST RELEASE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 500 mg Product Characteristics Color WHITE Score Shape Size Flavor CITRUS Imprint Code Contains 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 OTC MONOGRAPH FINAL part341 06/30/2010 Labeler - Bayer Corporation Consumer Care Division (785159372)