| NDC Code | 70000-0486-1 |
|---|
| Package Description | 355 mL in 1 BOTTLE (70000-0486-1) |
|---|
| Product NDC | 70000-0486 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Leader Antacid |
|---|
| Non-Proprietary Name | Aluminum Hydroxide, Magnesium Hydroxide, Simethicone |
|---|
| Dosage Form | SUSPENSION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20190423 |
|---|
| End Marketing Date | 20220430 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part332 |
|---|
| Manufacturer | Cardinal Health 110, LLC. dba Leader |
|---|
| Substance Name | ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE |
|---|
| Strength | 400; 40; 400 |
|---|
| Strength Unit | mg/10mL; mg/10mL; mg/10mL |
|---|
| Pharmacy Classes | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
|---|