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FDA Product

POLMON

Product approved by U.S. Food and Drug Administration (US)

Basic Information

POLMON

64543-600

Regulatory Information

64543-600

ANDA202520

C73584

August 21, 2023

USA

POLMON (Dexchlorpheniramine Maleate Oral Solution, USP)

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

124568093

Active Ingredients

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

MENTHOL

Code: L7T10EIP3A

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

TRISODIUM CITRATE DIHYDRATE

Code: B22547B95K

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

DEXCHLORPHENIRAMINE MALEATE

Quantity: 2 mg in 5 mL

Code: B10YD955QW

Class Code: ACTIB

Active Moieties

DEXCHLORPHENIRAMINE

Code: 3Q9Q0B929N

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