BAYER ADVANCED ASPIRIN REGULAR STRENGTH-

Transcription

1 BAYER ADVANCED ASPIRIN REGULAR STRENGTH- aspirin tablet Bayer Corporation Cons umer Care Divis ion 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 Advanced As pirin 325 mg Coated Tablet Drug Facts Active ingredient (in each tablet) Aspirin 325 mg (NSAID) 1 1 nonsteroidal anti-inflammatory drug Purpos es Pain reliever/fever reducer Uses temporarily relieves headache menstrual pain minor pain of arthritis muscle pain pain and fever of colds toothache Warnings Reye's s yndrome 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 facial swelling asthma (wheezing) 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

2 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 us e if you are allergic to aspirin or any other pain reliever/fever reducer 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 you have a sodium-restricted diet 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 breas t-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 s o by a doctor becaus e it may caus e 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 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 each tablet contains: sodium 47 mg

3 store at room temperature. Avoid excessive heat and moisture. Keep desiccant and product in original bottle. Immediately close cap tightly after use. save carton for full directions and warnings Inactive ingredients carnauba wax, colloidal silicon dioxide, hypromellose, sodium carbonate, zinc stearate Ques tions or comments? (Mon Fri 9AM 5PM EST) or PRINCIPAL DISPLAY PANEL mg Tablet Carton SEE NEW WARNINGS INFORMATION NEW! ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER BAYER ADVANCED ASPIRIN REGULAR STRENGTH 325mg 24 Coated Tablets PRO-RELEASE TECHNOLOGY FAST, SAFE PAIN RELIEF

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5 BAYER ADVANCED ASPIRIN REGULAR STRENGTH aspirin tablet Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC: Route of Ad minis tration ORAL Active Ing redient/active Moiety Ing redient Name Basis o f Streng th Streng th Aspirin (UNII: R16 CO5Y76 E) (Aspirin - UNII:R16 CO5Y76 E) Aspirin 325 mg Inactive Ing redients Ca rna uba Wa x (UNII: R12CBM0 EIZ) Silico n Dio xide (UNII: ETJ7Z6 XBU4) Hypro mello ses (UNII: 3NXW29 V3WO) So dium ca rbo na te (UNII: 45P326 1C7T) Zinc stea ra te (UNII: H9 2E6 QA4FV) Ing redient Name Streng th mg 8.50 mg mg mg mg Product Characteristics Color WHITE S core no sco re Shape ROUND Siz e 10 mm Flavor Imp rint Cod e BA;325 Contains Packag ing # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date 1 NDC: in 1 DRUM 2 NDC: in 1 CARTON 2 24 in 1 BOTTLE, PLASTIC 3 NDC: in 1 CARTON in 1 BOTTLE, PLASTIC Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC MONOGRAPH FINAL part343 12/0 1/20 10 Labeler - Bayer Corporation Cons umer Care Divis ion ( )

6 Revised: 3/2011 Bayer Corporation Consumer Care Division