Label: BAYER- aspirin tablet
- NDC Code(s): 66715-9726-2
- Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
Pain reliever/fever reducerClose
- muscle pain
- menstrual pain
- pain and fever of colds
- minor pain of arthritis
Children and teenagers who have or are recovering form 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:
- facial swelling
- 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
- 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
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.
- 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: consult a doctor
- Other information
- save carton for full directions and warnings
- store at room temperature
- Inactive ingredients
- Questions or comments?
1-800-331-4536 or www.bayeraspirin.comClose
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manufactured by Bayer CorporationClose
- PRINCIPAL DISPLAY PANEL - 4 Tablet Carton
ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER
THE WONDER DRUG®
Safe Pain Relief Plus
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9726 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) hypromelloses (UNII: 3NXW29V3WO) powdered cellulose (UNII: SMD1X3XO9M) triacetin (UNII: XHX3C3X673) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code BAYER;BAYER Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9726-2 2 in 1 CARTON 1 2 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 07/01/2009 Labeler - Lil' Drug Store Products, Inc. (093103646)