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

One or two capsules 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

Butalbital, acetaminophen, and caffeine capsules containing butalbital 50 mg (Warning: May be habit-forming) , acetaminophen 300 mg and caffeine 40 mg, are supplied in bottles of 100 capsules, NDC 51672-4222-1. Capsules are light blue gelatin capsule, size 0, with “TARO” over “ABC” printed in black ink on cap and body.

Store at 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure.

Rx only

Manufactured by:
Taro Pharmaceutical Industries Ltd.
Haifa Bay, Israel 2624761
Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Revised: May 2020
21360-0520-1

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Label

NDC 51672-4222-1
100 Capsules

Butalbital,
Acetaminophen
and Caffeine
Capsules, USP

50 mg, 300 mg
and 40 mg

Each capsule contains:
Butalbital 50 mg
(WARNING: May be habit-forming)
Acetaminophen 300 mg
Caffeine 40 mg

Rx only

TARO

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE butalbital, acetaminophen, and caffeine capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4222 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Butalbital (Butalbital) Butalbital 50 mg Acetaminophen (Acetaminophen) Acetaminophen 300 mg Caffeine (Caffeine) Caffeine 40 mg

Inactive Ingredients Ingredient Name Strength microcrystalline cellulose stearic acid talc FD&C blue no. 1 FD&C red no. 40 gelatin, unspecified sodium lauryl sulfate titanium dioxide POVIDONE, UNSPECIFIED

Product Characteristics Color BLUE (Light Blue) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code TARO;ABC Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51672-4222-1 100 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213046 07/01/2020

Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceutical Industries, Ltd.		600072078	MANUFACTURE (51672-4222)

Revised: 08/2020 Taro Pharmaceuticals U.S.A., Inc.