| Product NDC: | 0603-0894 |
| Proprietary Name: | Infants Simethicone |
| Non Proprietary Name: | Simethicone |
| Active Ingredient(s): | 63.3; 3.7 mg/mL; mg/mL & nbsp; Simethicone |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0603-0894 |
| Labeler Name: | Qualitest Pharmaceuticals |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | part332 |
| Marketing Category: | OTC MONOGRAPH FINAL |
| Start Marketing Date: | 19971016 |
| Package NDC: | 0603-0894-50 |
| Package Description: | 1 BOTTLE in 1 CARTON (0603-0894-50) > 30 mL in 1 BOTTLE |
| NDC Code | 0603-0894-50 |
| Proprietary Name | Infants Simethicone |
| Package Description | 1 BOTTLE in 1 CARTON (0603-0894-50) > 30 mL in 1 BOTTLE |
| Product NDC | 0603-0894 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Simethicone |
| Dosage Form Name | SOLUTION/ DROPS |
| Route Name | ORAL |
| Start Marketing Date | 19971016 |
| Marketing Category Name | OTC MONOGRAPH FINAL |
| Labeler Name | Qualitest Pharmaceuticals |
| Substance Name | DIMETHICONE; SILICON DIOXIDE |
| Strength Number | 63.3; 3.7 |
| Strength Unit | mg/mL; mg/mL |
| Pharmaceutical Classes |