BUTALBITAL AND ACETAMINOPHEN
Butalbital and Acetaminophen Tablets, 50 mg/325 mg and 50 mg/300 mg Rx only
0a8a6a16-b23f-45d2-b5d4-540264e74d14
HUMAN PRESCRIPTION DRUG LABEL
Dec 15, 2022
Burel Pharmaceuticals, LLC
DUNS: 609436204
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
butalbital and acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
butalbital and acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 35573-455-02
Butalbital and Acetaminophen Tablets
50 mg / 300 mg
100 Tablets
Rx only
NDC: 35573-456-02
Butalbital and Acetaminophen Tablets
50 mg / 325 mg
100 Tablets
Rx only
DESCRIPTION SECTION
DESCRIPTION
Each Butalbital and acetaminophen tablets, 50 mg/ 325 mg for oral administration contains:
*Butalbital, USP………...….. 50 mg
Acetaminophen, USP..……. 325 mg
Each Butalbital and acetaminophen tablets, 50 mg/ 300 mg for oral administration contains:
*Butalbital, USP………...….. 50 mg
Acetaminophen, USP..……. 300 mg
- Habit forming ingredient
In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Silicified Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Pregelatinized Starch, Povidone, Crospovidone and Stearic Acid.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula:
C11H16N2O3 M.W.=224.26
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
C8H9NO2 M.W.=151.16