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

Principal Display Panel -- 100 Capsule Bottle Label
(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: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.

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