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Topcare Migraine Formula

Generic Name: acetaminophen, aspirin, caffeine
Dosage Form: tablet

Topco Migraine Formula Drug Facts

Active ingredient (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Slideshow: Living with Your Migraines: Tips for Treatment and Prevention

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

Uses

  • 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 are allergic to acetaminophen
  • if you have ever had an allergic reaction to 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 liver disease
  • 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 have 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 problems or serious side effects from taking pain relievers or fever reducers
  • you have vomiting with your migraine headache
  • 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
  • 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

When using this product

  • take with food or milk if stomach upset occurs
  • long-term continuous use may increase the risk of heart attack or stroke

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
  • stomach pain or upset gets worse or lasts
  • 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.

Overdose warning: Taking more than the recommended dose can cause serious health problems, including serious liver damage. 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 (see Overdose warning)
  • 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 lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

Questions or comments?

1-888-423-0139

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See New Warnings Information

with Caffeine

Migraine Formula

Acetaminophen/Aspirin (NSAID)/Caffeine Tablets, USP

Pain Reliever/Pain Reliever Aid

actual size

Compare to Excedrin® Migraine active ingredients

†Capsule-Shaped Tablets

Migraine Formula Carton

Topcare Migraine Formula 
acetaminophen, aspirin, caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-374
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
ASPIRIN (ASPIRIN) ASPIRIN 250 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code L374
Contains         
Packaging
# Item Code Package Description
1 NDC:36800-374-62 1 BOTTLE (BOTTLE) in 1 CARTON
1 24 TABLET (TABLET) in 1 BOTTLE
2 NDC:36800-374-78 1 BOTTLE (BOTTLE) in 1 CARTON
2 100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077114 04/01/2003
Labeler - Topco Associates LLC (006935977)
Revised: 04/2010
 
Topco Associates LLC



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