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USFDA APPLICATION NUMBER - 21963 / DOSAGE - SUSPENSION;ORAL - 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| fexofenadine hydrochloride(UNII: 2S068B75ZU) (fexofenadine - UNII:E6582LOH6V) | fexofenadine hydrochloride | 6mg in 1 | 180mg | 60mg | 30mg | 30mg |
Inactive Ingredients
| Ingredient Name | sanofi-aventis U.S. LLC | Chattem, Inc. |
|---|---|---|
| anhydrous citric acid(XF417D3PSL) | ||
| aspartame(Z0H242BBR1) | ||
| butylparaben(3QPI1U3FV8) | ||
| cellulose acetate(3J2P07GVB6) | ||
| cellulose, microcrystalline(OP1R32D61U) | ||
| croscarmellose sodium(M28OL1HH48) | ||
| crospovidone(68401960MK) | ||
| EDETATE DISODIUM(7FLD91C86K) | ||
| hypromelloses(3NXW29V3WO) | ||
| magnesium stearate(70097M6I30) | ||
| mannitol(3OWL53L36A) | ||
| poloxamer 407(TUF2IVW3M2) | ||
| polyethylene glycols(3WJQ0SDW1A) | ||
| POTASSIUM SORBATE(1VPU26JZZ4) | ||
| povidone K30(U725QWY32X) | ||
| povidone(FZ989GH94E) | ||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||
| propylparaben(Z8IX2SC1OH) | ||
| silicon dioxide(ETJ7Z6XBU4) | ||
| sodium bicarbonate(8MDF5V39QO) | ||
| sodium chloride(451W47IQ8X) | ||
| sodium phosphate, dibasic, heptahydrate(70WT22SF4B) | ||
| sodium phosphate, monobasic, monohydrate(593YOG76RN) | ||
| sucrose(C151H8M554) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||
| WATER(059QF0KO0R) | ||
| XANTHAN GUM(TTV12P4NEE) | ||
| xylitol(VCQ006KQ1E) |
