ULTRACET (Page 12 of 12)

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

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

55289617 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:55289-617(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:55289-617-20 20 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021123 08/15/2001
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (55289-617)

Revised: 03/2018 PD-Rx Pharmaceuticals, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.