ULTRACET (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — 37.5 mg/325 mg Tablet Bottle Label

NDC 50458-650-60

ULTRACET®
CIV
(37.5 mg tramadol
HCl/325 mg
acetaminophen
tablets)

Please see the
Medication
Guide provided
by your pharmacist.

Keep out of reach of children.

Rx only 100 tablets

PRINCIPAL DISPLAY PANEL -- 37.5 mg/325 mg Tablet Bottle Label
(click image for full-size original)
ULTRACET tramadol hydrochloride and acetaminophen tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-650
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tramadol hydrochloride (tramadol) tramadol hydrochloride 37.5 mg
acetaminophen (acetaminophen) acetaminophen 325 mg
Inactive Ingredients
Ingredient Name Strength
powdered cellulose
SODIUM STARCH GLYCOLATE TYPE A POTATO
starch, corn
magnesium stearate
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
polysorbate 80
titanium dioxide
FERROSOFERRIC OXIDE
carnauba wax
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape OVAL (capsule-shaped) Size 15mm
Flavor Imprint Code O;M;650
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-650-60 100 TABLET, COATED in 1 BOTTLE None
2 NDC:50458-650-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
2 10 TABLET, COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50458-650-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021123 08/15/2001
Labeler — Janssen Pharmaceuticals, Inc. (063137772)
Establishment
Name Address ID/FEI Operations
Janssen Ortho, LLC 805887986 MANUFACTURE (50458-650), ANALYSIS (50458-650)
Establishment
Name Address ID/FEI Operations
Mallinckrodt, Inc. 097722284 API MANUFACTURE (50458-650)
Establishment
Name Address ID/FEI Operations
Proto Chemicals AG 480008890 API MANUFACTURE (50458-650)

Revised: 10/2019 Janssen Pharmaceuticals, Inc.

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