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USFDA APPLICATION NUMBER - 88629 / DOSAGE - TABLET;ORAL - 300MG;60MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ACETAMINOPHEN(UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) | ACETAMINOPHEN | 300mg |
| CODEINE PHOSPHATE(UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) | CODEINE PHOSPHATE | 60mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions LLC | Avera McKennan Hospital | NuCare Pharmaceuticals, Inc. | Par Pharmaceutical, Inc. | PD-Rx Pharmaceuticals, Inc. | Quality Care Products, LLC | REMEDYREPACK INC. | Bryant Ranch Prepack | Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals, Inc. | Teva Pharmaceuticals USA, Inc. | A-S Medication Solutions | Clinical Solutions Wholesale, LLC | SpecGx LLC | American Health Packaging | Janssen Pharmaceuticals, Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | ||||||||||||||||
| CROSPOVIDONE (120 .MU.M)(68401960MK) | ||||||||||||||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||||||||||||||||
| CROSPOVIDONE(2S7830E561) | ||||||||||||||||
| CROSPOVIDONE(68401960MK) | ||||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||||||||
| POVIDONE(FZ989GH94E) | ||||||||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||||||||||||
| POVIDONES(FZ989GH94E) | ||||||||||||||||
| powdered cellulose(SMD1X3XO9M) | ||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||||||||||||
| SODIUM METABISULFITE(4VON5FNS3C) | ||||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||||||||
| STEARIC ACID(4ELV7Z65AP) |
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