Tussnex FM Cold, Flu and Sore Throat is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Guardian Drug Company. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.
| Product ID | 53041-618_111aa6dd-ced2-4a31-b8f5-9d971ea920c6 |
| NDC | 53041-618 |
| Product Type | Human Otc Drug |
| Proprietary Name | Tussnex FM Cold, Flu and Sore Throat |
| Generic Name | Acteaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl |
| Dosage Form | Liquid |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-12-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | Guardian Drug Company |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Active Ingredient Strength | 650 mg/20mL; mg/20mL; mg/20mL; mg/20mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2012-12-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-12-01 |
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/20mL |
| SPL SET ID: | 7bddce11-c227-4d95-94c1-6f41ecd7285b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 53041-618 | Tussnex FM Cold, Flu and Sore Throat | Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
| 49348-080 | adult cold, flu and sore throat | acteaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl |
| 67091-221 | Childrens Multi-Symptom Cold and Fever Relief | Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
| 53041-622 | Childrens Tussnex | Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |