Chlorpheniramine / Ibuprofen / Phenylephrine Oral Tablet

Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Pfizer Consumer Healthcare (2014-12-29)
Oldest Current Product
2012-07-23
License(s)
NDA
RxNORM
ORAL TABLET\CHLORPHENIRAMINE:IBUPROFEN:PHENYLEPHRINE
FDAOB
ORAL\TABLET\CHLORPHENIRAMINE MALEATE: IBUPROFEN: PHENYLEPHRINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, COATED\CHLORPHENIRAMINE MALEATE: IBUPROFEN: PHENYLEPHRINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, COATED\CHLORPHENIRAMINE: IBUPROFEN: PHENYLEPHRINE

product(s) by strength(s)

chlorpheniramine maleate 4 mg / ibuprofen 200 mg / phenylephrine hydrochloride 10 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005730196NDAPfizer Consumer Healthcare2012-07-23CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDEORALTABLET, COATEDNDA022113a6cc97d8-252a-4527-a470-6d9e356342fd

application(s)

#idtitleapplicantapprovedapproved drug
1NDA022113ADVIL ALLERGY AND CONGESTION RELIEFPFIZER INC2011-12-21NDA022113_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022113_001OTCIBUPROFEN (200MG), PHENYLEPHRINE HYDROCHLORIDE (10MG), CHLORPHENIRAMINE MALEATE (4MG)ORALTABLETTrue2011-12-21ADVIL ALLERGY AND CONGESTION RELIEF

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a6cc97d8-252a-4527-a470-6d9e356342fd (view SPL)Advil ALLERGY & CONGESTION RELIEFotcHuman OTCPfizer Consumer HealthcareANALYSIS, LABEL, MANUFACTURE, PACK2014-12-294005730196

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII