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Drug Product Composition: Dexchloropheniramine Maleate

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USFDA APPLICATION NUMBER - 207768 / DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE(UNII: V1Q0O9OJ9Z)
(CHLORPHENIRAMINE - UNII:3U6IO1965U)
CHLORPHENIRAMINE MALEATE2.8mg in 5
CODEINE PHOSPHATE ANHYDROUS(UNII: 2X585M1M3T)
(CODEINE - UNII:Q830PW7520)
CODEINE PHOSPHATE ANHYDROUS14.7mg in 5

Inactive Ingredients

Ingredient Name
Aytu BioPharma, Inc.
Vernalis Therapeutics, Inc.
CITRIC ACID ACETATE(DSO12WL7AU)
D&C RED NO. 30(2S42T2808B)
ETHYL MALTOL(L6Q8K29L05)
GLYCERIN(PDC6A3C0OX)
METHYLPARABEN(A2I8C7HI9T)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ACETATE(32K497ZK2U)
POVIDONE K30(U725QWY32X)
PROPYL GALLATE(8D4SNN7V92)
PROPYLPARABEN(Z8IX2SC1OH)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM POLYSTYRENE SULFONATE(1699G8679Z)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TRIACETIN(XHX3C3X673)
WATER(059QF0KO0R)
XANTHAN GUM(TTV12P4NEE)