NDC Code(s) : 11584-4770-1
Packager : International Ethical Labs.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RelagesicAcetaminophen and Phenyltoloxamine Citrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11584-4770
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen(UNII: 362O9ITL9D)
(acetaminophen - UNII:362O9ITL9D) 		Acetaminophen500 mg
Phenyltoloxamine Citrate(UNII: 8UE48MJH8M)
(Phenyltoloxamine - UNII:K65LB6598J) 		Phenyltoloxamine Citrate29 mg
Inactive Ingredients
Ingredient Name Strength
Magnesium Stearate(UNII: 70097M6I30)
Cellulose, Microcrystalline(UNII: OP1R32D61U)
Tricalcium Phosphate(UNII: K4C08XP666)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (Capsule shape) Size 18 mm
Flavor Imprint Code Relagesic;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11584-4770-1100 in 1 BOTTLE, DISPENSING Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 02/15/2015

PRINCIPAL DISPLAY PANEL

NDC 11584-477-01

Strong Effective Pain Reliever

Relagesic

100 Tablets

Each tablet contains:
Acetaminophen    500 mg
Phenyltoloxamine Citrate    29 mg

Caffeine Free
Multi-Symptom Relief of Cramps,
Backache, Headache, and Bloating

Principal Display Panel - 100 Tablet Bottle Label