Label: FORTOLIN- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 51467-127-24 - Packager: FORTUNE PHARMACAL COMPANY, LIMITED
- 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 June 23, 2014
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FORTOLIN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51467-127 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code F;O;R;T;O;L;I;N Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51467-127-24 24 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/01/2004 Labeler - FORTUNE PHARMACAL COMPANY, LIMITED (686280561) Establishment Name Address ID/FEI Business Operations FORTUNE PHARMACAL COMPANY, LIMITED 686280561 manufacture(51467-127)