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 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Product: 50090-2105

NDC: 50090-2105-0 30 TABLET in a BOTTLE

NDC: 50090-2105-3 100 TABLET in a BOTTLE, PLASTIC

Storage

Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured By: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724

Butalbital, Acetaminophen and Caffeine

Label Image

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE butalbital, acetaminophen and caffeine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2105(NDC:0143-1787) Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUTALBITAL (BUTALBITAL) BUTALBITAL 50 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg CAFFEINE (CAFFEINE) CAFFEINE 40 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID

Product Characteristics Color BLUE (BLUE) Score no score Shape ROUND (ROUND) Size 11mm Flavor Imprint Code West;ward;787 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50090-2105-5 60 TABLET in 1 BOTTLE None 2 NDC:50090-2105-0 30 TABLET in 1 BOTTLE None 3 NDC:50090-2105-3 100 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089718 06/12/1995

Labeler — A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Operations
A-S Medication Solutions		830016429	RELABEL (50090-2105), REPACK (50090-2105)

Revised: 02/2021 A-S Medication Solutions