CARISOPRODOL by DIRECT RX CARISOPRODOL tablet

CARISOPRODOL by

Drug Labeling and Warnings

CARISOPRODOL by is a Prescription medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORM AND STRENGTH

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATION

9 DRUG ABUSE AND DEPENDENCE

10 OVERDOSAGE

11 DESCRIPTION

12 CLINCIAL PHARMACOLOGY

13 NONCLINICAL TOXICOLOGY

14 CLINICAL STUDIES

15 STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CARISOPRODOL 
carisoprodol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-768(NDC:64980-174)
Route of Administration	ORAL	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)	CARISOPRODOL	350 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	CL;022
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-768-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040823	04/01/2016

Labeler - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	repack(61919-768)