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FDA Product

Sildec PE DM

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

Basic Information

Sildec PE DM

21695-900

Regulatory Information

21695-900

January 26, 2011

CHLORPHENIRAMINE / PHENYLEPHRINE/ DEXTROMETHORPHAN Syrup (CPM/PE/DM Syrup)

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

118802834

Active Ingredients

CHLORPHENIRAMINE MALEATE

Quantity: 4 mg in 5 mL

Code: V1Q0O9OJ9Z

Class Code: ACTIB

PHENYLEPHRINE HYDROCHLORIDE

Quantity: 12.5 mg in 5 mL

Code: 04JA59TNSJ

Class Code: ACTIB

DEXTROMETHORPHAN HYDROBROMIDE

Quantity: 15 mg in 5 mL

Code: 9D2RTI9KYH

Class Code: ACTIB

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

D&C RED NO. 33

Code: 9DBA0SBB0L

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

Active Moieties

DEXTROMETHORPHAN

Code: 7355X3ROTS

CHLORPHENIRAMINE

Code: 3U6IO1965U

PHENYLEPHRINE

Code: 1WS297W6MV

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