MIGRENOL- acetaminophen, caffeine tablet 
Four Ventures Enterprises, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug facts

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

Caffeine -65 mg (Pain reliever aid).

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

 headache, muscular aches,

toothache, premenstrual and menstrual cramps

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.

- 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.

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

Keep out of reach of children.

INACTIVE INGREDIENTS: Croscarmellose Sodium, Dicalcium,

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

Sodium Starch Glycolate, Starch, Stearic Acid.

Pupose: Pain reliever, Fever Reducer

image description

MIGRENOL 
acetaminophen, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69293-565
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE6 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (snow white) Scoreno score
ShapeROUND (NONE) Size19mm
FlavorImprint Code NONE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69293-565-1616 in 1 BOX; Type 0: Not a Combination Product11/10/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/10/2014
Labeler - Four Ventures Enterprises, Inc. (944548866)
Registrant - Four Ventures Enterprises, Inc. (944548866)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(69293-565)

Revised: 11/2018
Document Id: c6a6457c-70ab-44da-93cd-5c6e8aef21c4
Set id: b27fa5fe-a72a-4afe-8492-8fc871e6be65
Version: 2
Effective Time: 20181114
 
Four Ventures Enterprises, Inc.