Bayer Migraine Formula

Dosage form: tablet
Ingredients: Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg
Labeler: Bayer HealthCare LLC, Consumer Care
NDC Code: 0280-2030

Bayer Migraine Formula

Drug Facts

Active ingredients
(in each caplet)
Purposes
nonsteroidal anti-inflammatory drug
Acetaminophen 250 mgPain reliever
Aspirin 250 mg (NSAID)Pain reliever
Caffeine 65 mgPain reliever aid

Use
  • treats migraine

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

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

Caffeine warning

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 heart beat.

Do not use
  • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/ fever reducer
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if
  • you have never had migraines diagnosed by a health professional
  • you have a headache that is different from your usual migraines
  • you have the worst headache of your life
  • you have fever and stiff neck
  • you have headaches beginning after or caused by head injury, exertion, coughing or bending
  • you experienced your first headache after the age of 50
  • you have daily headaches
  • you have a migraine so severe as to require bed rest
  • you have liver disease
  • 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 problems or serious side effects from taking pain relievers or fever reducers
  • you have vomiting with your migraine headache

Ask a doctor or pharmacist before use if you are
  • taking a prescription drug for:
    • anticoagulation (thinning of the blood)
    • diabetes
    • gout
    • arthritis
  • under a doctor's care for any serious condition
  • taking any other drug
  • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

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
  • your migraine is not relieved or worsens after first dose
  • new or unexpected symptoms occur
  • ringing in the ears or 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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not use more than directed
  • adults: take 2 caplets with a glass of water
  • if symptoms persist or worsen, ask your doctor
  • do not take more than 2 caplets in 24 hours, unless directed by a doctor
  • under 18 years of age: ask a doctor

Other information
  • store at 20° - 25° C (68° - 77° F)
  • read all product information before using. Keep this box for important information.

Inactive ingredients

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

Questions or comments?

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

Distributed by:
Bayer HealthCare LLC
Consumer Care
P.O. Box 1910
Morristown, NJ 07962-1910 USA

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

BAYER®

MIGRAINE
FORMULA

ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE TABLETS
PAIN RELIEVER/ PAIN RELIEVER AID

50 Coated Caplets** **Capsule-Shaped Tablets

BAYER MIGRAINE FORMULA 
acetaminophen, aspirin, and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-2030
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen250 mg
Aspirin (Aspirin) Aspirin250 mg
Caffeine (Caffeine) Caffeine65 mg
Inactive Ingredients
Ingredient NameStrength
FD&C blue NO. 1 
Carnauba wax 
Crospovidone 
Hypromelloses 
Cellulose, Microcrystalline 
povidones 
propylene glycol 
Saccharin Sodium Dihydrate 
Stearic acid 
titanium dioxide 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize21mm
FlavorImprint CodeL374
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-2030-501 BOTTLE in 1 CARTON
150 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07579406/26/2012
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 10/2012
 
Bayer HealthCare LLC, Consumer Care

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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