Butalbital, Acetaminophen, and Caffeine (Page 3 of 3)

Treatment

A single or multiple 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

Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed “1695” on one side and “LCI” on the other side and are supplied in bottles of 20 NDC 68071-3249-

bottles of 30 NDC 68071-3249-3

bottles of 60 NDC 68071-3249-6

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

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

Made in the USA

CIB70307B

Rev. 04/16

PRINCIPAL DISPLAY PANEL

pdp
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BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE
butalbital, acetaminophen, and caffeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3249(NDC:0527-1695)
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
CROSCARMELLOSE SODIUM
STARCH, CORN
STEARIC ACID
SILICON DIOXIDE
MAGNESIUM STEARATE
FD&C BLUE NO. 1
Product Characteristics
Color blue (Light-blue, speckled) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code LCI;1695
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-3249-2 20 TABLET in 1 BOTTLE None
2 NDC:68071-3249-3 30 TABLET in 1 BOTTLE None
3 NDC:68071-3249-6 60 TABLET in 1 BOTTLE None
4 NDC:68071-3249-0 10 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200243 09/13/2012
Labeler — NuCare Pharmaceuticals, Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCre Pharmaceuticals, Inc. 010632300 repack (68071-3249)

Revised: 04/2023 NuCare Pharmaceuticals, Inc.

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