<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
52083-249-60
</NDCCode>
<PackageDescription>
60 TABLET, COATED in 1 BOTTLE (52083-249-60)
</PackageDescription>
<NDC11Code>
52083-0249-60
</NDC11Code>
<ProductNDC>
52083-249
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Guaifenesin Phenylephrine Dextromethorphan
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Guaifenesin, Phenylephrine Hcl, Dextromethorphan
</NonProprietaryName>
<DosageFormName>
TABLET, COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20120718
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH FINAL
</MarketingCategoryName>
<ApplicationNumber>
part341
</ApplicationNumber>
<LabelerName>
Kramer Novis.
</LabelerName>
<SubstanceName>
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
400; 20; 10
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1; mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2018-12-04
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
E
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20171231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>