USFDA APPLICATION NUMBER - 85055 / DOSAGE - TABLET;ORAL - 300MG;30MG
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 | 30mg |
Inactive Ingredients
Ingredient Name | A-S Medication Solutions | A-S Medication Solutions LLC | Amneal Pharmaceuticals LLC | Avera McKennan Hospital | Cardinal Health | Mckesson Packaging Services a business unit of McKesson Corporation | NuCare Pharmaceuticals, Inc. | NuCare Pharmaceuticals,Inc. | NuCarePharmaceuticals, Inc. | Par Pharmaceutical, Inc. | PD-Rx Pharmaceuticals, Inc. | Quality Care Products, LLC | REMEDYREPACK INC. | St. Mary's Medical Park Pharmacy | Bryant Ranch Prepack | Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals, Inc. | Teva Pharmaceuticals USA, Inc. | 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) | ||||||||||||||||||||||
CROSPOVIDONE, UNSPECIFIED(2S7830E561) | ||||||||||||||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||||||||||||||
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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