ShopRite Migraine Formula

Wakefern Food Corporation

ShopRite Migraine Formula Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purpose
• ShopRite Migraine Formula Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• ShopRite Migraine Formula Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

ShopRite Migraine Formula 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 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-SHOPRITE

Principal Display Panel

Compare to: Active Ingredients in Excedrin® Migraine

SEE NEW WARNINGS INFORMATION

MIGRAINE FORMULA

Acetaminophen, Aspirin (NSAID) and Caffeine Tablets

Pain Reliever – Pain Reliever Aid

100 coated caplets**

(**capsule shaped tablets)