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Drug Product Composition: AM20060782

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$ API Ref.Price (USD/KG) : 12Xls

USFDA APPLICATION NUMBER - 21374 / DOSAGE - CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN(UNII: WK2XYI10QM)
(IBUPROFEN - UNII:WK2XYI10QM)
IBUPROFEN200mg
PSEUDOEPHEDRINE HYDROCHLORIDE(UNII: 6V9V2RYJ8N)
(PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
PSEUDOEPHEDRINE HYDROCHLORIDE30mg

Inactive Ingredients

Ingredient Name
Haleon US Holdings LLC
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C RED NO. 40(WZB9127XOA)
GELATIN, UNSPECIFIED(2G86QN327L)
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POTASSIUM HYDROXIDE(WZH3C48M4T)
SORBITAN(6O92ICV9RU)
SORBITOL(506T60A25R)
WATER(059QF0KO0R)