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migraine relief

CVS Pharmacy

CVS Pharmacy, Inc. Migraine Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain 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

migraine relief 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?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients in Excedrin® Migraine

See new warnings information

MIGRAINE RELIEF

ACETAMINOPHEN, ASPIRIN (NSAID) & CAFFEINE TABLETS

PAIN RELIEVER / PAIN RELIEVER AID

200 COATED CAPLETS†

†CAPSULE-SHAPED TABLETS

migraine relief

acetaminophen, aspirin, caffeine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-374
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 250 mg
aspirin ASPIRIN 250 mg
CAFFEINE 65 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
CROSPOVIDONE
cellulose, microcrystalline
POVIDONES
propylene glycol
saccharin sodium
STEARIC ACID
titanium dioxide
HYPROMELLOSES

Product Characteristics

Color Size Imprint Code Shape
WHITE 17 mm L374 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 100 in 1 BOTTLE
3 200 in 1 BOTTLE
4 NDC:59779-374-82 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075794 2002-08-27


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Be sure to consult your doctor before taking any medication!
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