MIGRENOL- acetaminophen, caffeine tablet

Migrenol by

Drug Labeling and Warnings

Migrenol by is a Otc medication manufactured, distributed, or labeled by Four Ventures Enterprises, Inc., ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet): Acetaminophen -500 mg, (Pain reliever),

Caffeine -65 mg (Pain reliever aid).

INDICATIONS & USAGE

temporary relief of occasional headaches and minor aches and pains due to

 headache, muscular aches,

toothache, premenstrual and menstrual cramps

WARNINGS

DO NOT USE:

- with any other product containing acetaminophen

- if you ever had an allergic reaction to any other pain reliever/fever reducer.

ASK DOCTOR BEFORE USE if you have liver desease.

ASK A DOCTOR OR PHARMACIST BEFORE USE if you are taking sedatives or tranquilizers when using this product

- drowsiness will occur

- avoid alcoholic drinks

STOP USE AND ASK A DOCTOR IF

- an allergic reaction occurs. Seek medical help right away.

-new symptoms occur

- pain gets worse or lasts more than 10 days

- fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

LIVER WARNING: This product contains acetaminophen.

Severe liver damage may occur if you take

more than 8 tables in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product.

DOSAGE & ADMINISTRATION

- do not take more than directed

Adults and children 12 years and over:

- take 2 tablets every 6 hours

- do not take more than 8 tablets in 24 hours

Children under 12 years: do not use this adult product in children under 12 years of age: this will provide more than the recommended dose

and may cause liver damage.

PREGNANCY OR BREAST FEEDING

IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Croscarmellose Sodium, Dicalcium,

Phosphate, Hypromellose, Microcrystalline Cellulose, Polydextrose, Polyethylene glycol, Povidone, Silica,

Sodium Starch Glycolate, Starch, Stearic Acid.

PURPOSE

Pupose: Pain reliever, Fever Reducer

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIGRENOL 
acetaminophen, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69293-565
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	6 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (NONE)	Size	19mm
Flavor		Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69293-565-16	16 in 1 BOX; Type 0: Not a Combination Product	11/10/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/10/2014

Labeler - Four Ventures Enterprises, Inc. (944548866)

Registrant - Four Ventures Enterprises, Inc. (944548866)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(69293-565)