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USFDA APPLICATION NUMBER - 19123 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MEQ
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| Potassium Chloride(UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152) | Potassium Chloride | 750mg | 600mg |
Inactive Ingredients
| Ingredient Name | Aphena Pharma Solutions - Tennessee, LLC | Cardinal Health | Legacy Pharmaceutical Packaging | Liberty Pharmaceuticals, Inc. | REMEDYREPACK INC. | Upsher-Smith Laboratories, Inc. | Vensun Pharmaceuticals, Inc. | Mckesson Rxpak Inc | NCS HealthCare of KY, Inc dba Vangard Labs | REMEDYREPACK INC. | Sandoz Inc. | Bryant Ranch Prepack | Denton Pharma, Inc. dba Northwind Pharmaceuticals | Lake Erie Medical DBA Quality Care Products LLC | Mylan Institutional Inc. | A-S Medication Solutions | A-S Medication Solutions LLC | American Health Packaging | PD-Rx Pharmaceuticals, Inc. | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | St Marys Medical Park Pharmacy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | |||||||||||||||||||||
| AMMONIUM LAURETH-5 SULFATE(43ZIH89I48) | |||||||||||||||||||||
| Carnauba Wax(R12CBM0EIZ) | |||||||||||||||||||||
| d&c yellow no. 10(35SW5USQ3G) | |||||||||||||||||||||
| ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62) | |||||||||||||||||||||
| ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV) | |||||||||||||||||||||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | |||||||||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||||||||||||
| FD&C YELLOW NO. 5(I753WB2F1M) | |||||||||||||||||||||
| fd&c yellow no. 6(H77VEI93A8) | |||||||||||||||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||||||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||||||||||||
| HYDROGENATED COTTONSEED OIL(Z82Y2C65EA) | |||||||||||||||||||||
| magnesium stearate(70097M6I30) | |||||||||||||||||||||
| POLYETHYLENE GLYCOL(3WJQ0SDW1A) | |||||||||||||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||||||||||||
| polyethylene glycols(3WJQ0SDW1A) | |||||||||||||||||||||
| POLYVINYL ALCOHOL(532B59J990) | |||||||||||||||||||||
| polyvinyl alcohol, unspecified(532B59J990) | |||||||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||||||||
| STEARIC ACID(4ELV7Z65AP) | |||||||||||||||||||||
| TALC(7SEV7J4R1U) | |||||||||||||||||||||
| titanium dioxide(15FIX9V2JP) |
