Label: BAYER AM EXTRA STENGTH- aspirin and caffeine tablet
- NDC Code(s): 0280-2600-50
- Packager: Bayer HealthCare LLC, Consumer Care
- 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
- for the temporary relief of minor aches and pains associated with a hangover
- helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover
- also effective for headache, body aches and pains alone
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:
- 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
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- in children under 12 years of age
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
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
When using this product
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.
- the recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
- take for occasional use only. Do not use for more than 2 days for a hangover unless directed by a doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a doctor.
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 2 tablets every 6 hours not to exceed 8 tablets in 24 hours
- children under 12 years: consult a doctor
- Other information
store at room temperatureClose
- Inactive ingredients
carnauba wax, corn starch, hypromellose, powdered cellulose, triacetinClose
- Questions or comments?
1-800-331-4536 (Mon-Fri 9-5 EST) or www.bayeraspirin.comClose
- PRINCIPAL DISPLAY PANEL - 50 Tablet Carton
See new warnings information
Aspirin (NSAID)/Pain Reliever Caffeine/Alertness Aid
ASPIRIN + ALERTNESS AID
TARGETS TOUGH MORNING PAINS
- INGREDIENTS AND APPEARANCE
BAYER AM EXTRA STENGTH
aspirin and caffeine tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2600 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 500 mg Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 65 mg Product Characteristics Color WHITE Score no score Shape ROUND Size 25mm Flavor Imprint Code AM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-2600-50 1 in 1 CARTON 1 50 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/15/2010 Labeler - Bayer HealthCare LLC, Consumer Care (785159372)