BENZONATATE- benzonatate capsule, gelatin coated 
DIRECT RX

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BENZONATATE 200mg

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

WARNINGS

CONTRAINDICATIONS

PRECAUTIONS

ADVERSE REACTIONS

OVERDOSAGE

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

PRODUCT PACKAGING

BENZONATATE200 mg

BENZONATATE 
benzonatate capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-763(NDC:51224-001)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE200 mg
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize11mm
FlavorImprint Code N01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-763-2020 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20276502/15/2016
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-763)

Revised: 2/2016
Document Id: 2bd5ca08-ac44-2b22-e054-00144ff8d46c
Set id: 2bd5ca08-ac43-2b22-e054-00144ff8d46c
Version: 1
Effective Time: 20160215
 
DIRECT RX