Pentazocine Hydrochloride and Acetaminophen (Page 4 of 4)

DOSAGE AND ADMINISTRATION

Adult

The usual adult dose is 1 caplet every 4 hours as needed for pain relief, up to a maximum of 6 caplets per day.

Discontinuation

Due to the potential for withdrawal symptoms associated with abrupt discontinuation, consideration should be given to tapering patients off pentazocine hydrochloride and acetaminophen tablets after prolonged periods of treatment with pentazocine hydrochloride and acetaminophen tablets (See PRECAUTIONS, Drug Abuse and Dependence).

HOW SUPPLIED

Pentazocine Hydrochloride and Acetaminophen Tablets are light blue capsule shaped, tablets debossed “NL” on left side and “670” on right side of bisect and plain on the other side.

Bottles of 100 (NDC 43386-670-01).

Bottles of 100 (NDC 43386-670-05)

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP.]

Dispense in a tight, light-resistant container as defined in the USP.

DEA Order Form Required.

Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873

Distributed by:
GAVIS Pharmaceuticals, LLC
Somerset, NJ 08873

GIN-670-02
Rev: 06/2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fc01cb97-figure-03
(click image for full-size original)
PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN
pentazocine hydrochloride and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43386-670
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENTAZOCINE HYDROCHLORIDE (PENTAZOCINE) PENTAZOCINE HYDROCHLORIDE 25 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 1
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE Size 19mm
Flavor Imprint Code NL;670
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43386-670-01 100 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076202 05/11/2011
Labeler — GAVIS Pharmaceuticals, LLC (829838551)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 MANUFACTURE

Revised: 07/2011 GAVIS Pharmaceuticals, LLC

Page 4 of 4 1 2 3 4

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.