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Promethazine VC with Codeine Oral Solution

These highlights do not include all the information needed to use PROMETHAZINE VC WITH CODEINE ORAL SOLUTION CV safely and effectively. See full prescribing information for PROMETHAZINE VC WITH CODEINE ORAL SOLUTION CV. PROMETHAZINE VC WITH CODEINE ORAL SOLUTION (promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate) oral solution, CV Initial U.S. Approval: 1952

Approved
Approval ID

75c68c3a-8d8d-4a13-87de-3eb73608c943

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 22, 2024

Manufacturers
FDA

PAI Holdings, LLC

DUNS: 044940096

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0121-0925
Application NumberANDA040660
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2024
FDA Product Classification

INGREDIENTS (17)

CODEINE PHOSPHATEActive
Quantity: 10 mg in 5 mL
Code: GSL05Y1MN6
Classification: ACTIB
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: 04JA59TNSJ
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT

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Promethazine VC with Codeine Oral Solution - FDA Drug Approval Details