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Name:Bayeram Extra Stength
Manufacturer:Bayer Healthcare Llc, Consumer Care
Category:Over-the-counter (OTC) Marketed Drugs


BAYER® AM extra strength

BAYER AM EXTRA STENGTH - aspirin and caffeine tablet 
Bayer HealthCare LLC, Consumer Care

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.

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BAYER® AM extra strength

Drug Facts

Active ingredients (in each tablet) Purpose
*
nonsteroidal anti-inflammatory drug
Aspirin 500 mg (NSAID)* Pain reliever
Caffeine 65 mg Alertness aid

Uses

  • 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

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
  • 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
  • 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

  • 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
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs

When using this product

  • 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.

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

  • 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 temperature

Inactive ingredients

carnauba wax, corn starch, hypromellose, powdered cellulose, triacetin

Questions or comments?

1-800-331-4536 (Mon-Fri 9-5 EST) or www.bayeraspirin.com

PRINCIPAL DISPLAY PANEL - 50 Tablet Carton

See new warnings information

NEW!

Aspirin (NSAID)/Pain Reliever Caffeine/Alertness Aid

BAYER®

AM
extra strength
ASPIRIN + ALERTNESS AID

TARGETS TOUGH MORNING PAINS

Increases Alertness
Reduces Fatigue

50
TABLETS

PRINCIPAL DISPLAY PANEL - 50 Tablet Carton

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 (Aspirin) Aspirin 500 mg
Caffeine (Caffeine) Caffeine 65 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 25mm
Flavor Imprint Code AM
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0280-2600-50 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 50 TABLET ( TABLET) in 1 BOTTLE This package is contained within the CARTON (0280-2600-50)

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)

Revised: 03/2010 Bayer HealthCare LLC, Consumer Care



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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