Leader Migraine Formula

LEADER MIGRAINE FORMULA — acetaminophen, aspirin and caffeine tablet
REMEDYREPACK INC.

OTC — ACTIVE INGREDIENT

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

OTC — PURPOSE

Pain reliever

Pain reliever aid

INDICATIONS & USAGE

•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: Acetaminophen may cause severe skin reactions. Symptoms may include:

•skin reddening•blisters•rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

OTC — 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.

OTC — ASK DOCTOR

•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

OTC — ASK DOCTOR/PHARMACIST

•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

OTC — STOP USE

•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

OTC — PREGNANCY 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.

OTC — 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.

DOSAGE & ADMINISTRATION

•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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

OTC — QUESTIONS

1-800-719-9260

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Leader migraine formula

GENERIC: Acetaminophen, Aspirin, Caffeine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-195-36

ACTIVE INGREDIENT(S):

  • ACETAMINOPHEN 250mg in 1
  • ASPIRIN 250mg in 1
  • CAFFEINE 65mg in 1

INACTIVE INGREDIENT(S):

  • CARNAUBA WAX
  • SACCHARIN SODIUM
  • PROPYLENE GLYCOL
  • STEARIC ACID
  • POVIDONES
  • CELLULOSE, MICROCRYSTALLINE
  • CROSPOVIDONE
  • HYPROMELLOSES
  • TITANIUM DIOXIDE

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 17 mm

IMPRINT: L374

PACKAGING: 24 in 1 BOTTLE

MM1
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MM2
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LEADER MIGRAINE FORMULA
acetaminophen, aspirin, caffeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-195(NDC:37205-280)
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
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SACCHARIN SODIUM
PROPYLENE GLYCOL
STEARIC ACID
POVIDONES
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
HYPROMELLOSES
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE (TABLET) Size 17mm
Flavor Imprint Code L374
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61786-195-36 24 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075794 03/03/2015
Labeler — REMEDYREPACK INC. (829572556)

Revised: 03/2015 REMEDYREPACK INC.

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