BACZOL COLD MEDICINE is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Laboratorios Lopez S.a. De C.v.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Chlorpheniramine Maleate; Phenylephrine Hydrochloride.
| Product ID | 76864-208_3b921621-7d54-49dc-9e2a-ed0853d71fd2 |
| NDC | 76864-208 |
| Product Type | Human Otc Drug |
| Proprietary Name | BACZOL COLD MEDICINE |
| Generic Name | Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate, Phenylephrine Hcl |
| Dosage Form | Syrup |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-05-25 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | Laboratorios Lopez S.A. de C.V. |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
| Active Ingredient Strength | 250 mg/5mL; mg/5mL; mg/5mL; mg/5mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-05-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-05-25 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 49523-505 | Baczol Cold Medicine | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, and CHLORPHENIRAMINE MALEATE |
| 76864-208 | BACZOL COLD MEDICINE | ACETAMINOPHEN, DEXTROMETHORPHAN HBr, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCl |
| 76864-464 | Pulmo Calcio | ACETAMINOPHEN, DEXTROMETHORPHAN HBr, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCl |