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 ImageLabel 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

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