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Drug Product Composition: Promethazine Hydrochloride

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$ API Ref.Price (USD/KG) : 61Xls

USFDA APPLICATION NUMBER - 88761 / DOSAGE - SYRUP;ORAL - 5MG/5ML;6.25MG/5ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV)
PHENYLEPHRINE HYDROCHLORIDE5mg in 5
PROMETHAZINE HYDROCHLORIDE(UNII: R61ZEH7I1I)
(PROMETHAZINE - UNII:FF28EJQ494)
PROMETHAZINE HYDROCHLORIDE6.25mg in 5

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
Par Pharmaceutical
Preferred Pharmaceuticals, Inc.
Actavis Mid Atlantic LLC
Bryant Ranch Prepack
ALCOHOL(3K9958V90M)  
ANHYDROUS CITRIC ACID(XF417D3PSL)   
ASCORBIC ACID(PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE(2968PHW8QP)  
FD&C YELLOW NO. 6(H77VEI93A8)
MENTHOL(L7T10EIP3A)   
MENTHOL, UNSPECIFIED FORM(L7T10EIP3A)    
METHYLPARABEN(A2I8C7HI9T)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
SACCHARIN SODIUM(SB8ZUX40TY)  
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE(1Q73Q2JULR) 
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)    
SUCROSE(C151H8M554)
TANGERINE(KH3E3096OO)   
WATER(059QF0KO0R)