NDC Code(s) : 58657-401-01
Packager : Method Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Isometheptene-Dichloral-APAP Isometheptene Mucate, Dichloralphenazone, and Acetaminophen CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-401
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOMETHEPTENE MUCATE(UNII: 8O120FDS6P)
(ISOMETHEPTENE - UNII:Y7L24THH6T) 		ISOMETHEPTENE MUCATE65 mg
DICHLORALPHENAZONE(UNII: YYX637R279)
(CHLORAL HYDRATE - UNII:418M5916WG) 		DICHLORALPHENAZONE100 mg
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C RED NO. 40(UNII: WZB9127XOA)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code VSP1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58657-401-01100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/04/2014

PRINCIPAL DISPLAY PANEL

NDC 58657-401-01
Isometheptene-Dichloral- APAP Oral Capsules, USP
65 mg/100 mg/325 mg
Rx ONLY
100 CAPSULES

PRINCIPAL DISPLAY PANEL NDC 58657-401-01 Isometheptene-Dichloral- APAP Oral Capsules, USP 65 mg/100 mg/325 mg Rx ONLY 100 CAPSULES