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FDA Product

RYCLORA

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

Basic Information

RYCLORA

15370-150

Regulatory Information

15370-150

ANDA202520

C73584

January 8, 2024

USA

RYCLORA™ (dexchlorpheniramine maleate) Oral Solution, USP

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

079217215

Active Ingredients

propylene glycol

Code: 6DC9Q167V3

Class Code: IACT

Dexchlorpheniramine Maleate

Quantity: 2 mg in 5 mL

Code: B10YD955QW

Class Code: ACTIB

Citric Acid Monohydrate

Code: 2968PHW8QP

Class Code: IACT

FD&C Red No. 40

Code: WZB9127XOA

Class Code: IACT

glycerin

Code: PDC6A3C0OX

Class Code: IACT

menthol, unspecified form

Code: L7T10EIP3A

Class Code: IACT

methylparaben

Code: A2I8C7HI9T

Class Code: IACT

propylparaben

Code: Z8IX2SC1OH

Class Code: IACT

water

Code: 059QF0KO0R

Class Code: IACT

trisodium citrate dihydrate

Code: B22547B95K

Class Code: IACT

sucrose

Code: C151H8M554

Class Code: IACT

Active Moieties

Dexchlorpheniramine

Code: 3Q9Q0B929N

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