Butalbital, Acetaminophen and Caffeine (Page 3 of 3)

Treatment:

A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

DOSAGE AND ADMINISTRATION

Oral: one capsule every four hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

ZEBUTAL® Capsules brand of butalbital 50 mg, acetaminophen 500 mg and caffeine 40 mg are supplied as salmon/red capsules printed “170″ in white ink and are available in:

NDC 68453-170-10 Bottles of 100 capsules.

Store at 20-25o C (68-77o F) [See USP Controlled Room Temperature]. Protect from light and moisture.

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

Manufactured For:
Victory Pharma, Inc.
San Diego, CA 92130

Manufactured By:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724

Revised May 2011

ZEB-PI-4

PRINCIPAL DISPLAY PANEL

ZEBUTAL® Butalbital, Acetaminophen, Caffeine Capsules, USP
NDC 68453-170-10

Zebutal 50/500/40 mg
(click image for full-size original)

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
butalbital, acetaminophen and caffeine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68453-170
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTALBITAL (BUTALBITAL) BUTALBITAL 50 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
CAFFEINE (CAFFEINE) CAFFEINE 40 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO
COLLOIDAL SILICON DIOXIDE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
D&C RED NO. 33
D&C YELLOW NO. 10
FD&C RED NO. 40
GELATIN
Product Characteristics
Color RED (salmon) Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code 170
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68453-170-10 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040261 10/28/1998
Labeler — Victory Pharmaceutical (143180318)
Establishment
Name Address ID/FEI Operations
West-ward Pharmaceutical Corp 001230762 MANUFACTURE

Revised: 07/2011 Victory Pharmaceutical

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