CARISOPRODOL- carisoprodol tablet 
DIRECT RX

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CARISOPRODOL C-IV 350 mg 60 TABS

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

CARISOPRODOL C-IV 350mg

CARISOPRODOL 
carisoprodol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-768(NDC:64980-174)
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H) CARISOPRODOL350 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code CL;022
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-768-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04082304/01/2016
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-768)

Revised: 4/2016
Document Id: 305fa9bc-9752-0aad-e054-00144ff88e88
Set id: 305fa9bc-9751-0aad-e054-00144ff88e88
Version: 1
Effective Time: 20160413
 
DIRECT RX