Label: MIGRENOL- acetaminophen, caffeine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69293-565-16 - Packager: Four Ventures Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 14, 2018
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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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.
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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
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIGRENOL
acetaminophen, caffeine tabletProduct 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)
