Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by One2zee Limited Liability Company. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.
| Product ID | 55629-015_08fa64e1-619b-452e-9e2e-a6569daae95a |
| NDC | 55629-015 |
| Product Type | Human Otc Drug |
| Proprietary Name | Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl |
| Generic Name | Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl |
| Dosage Form | Capsule, Liquid Filled |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-03-01 |
| Marketing Category | OTC MONOGRAPH FINAL / |
| Application Number | part341 |
| Labeler Name | ONE2ZEE LIMITED LIABILITY COMPANY |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Active Ingredient Strength | 325 mg/1; mg/1; 1/1; 1/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-03-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 55629-015 | Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl | Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl |
| 69729-782 | Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl | Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl |
| 68016-224 | Childrens Cold, Cough and Sore Throat | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL |
| 69732-003 | Head and Cold | acetaminophen, guaifenesin, dextromethorphan HBr, phenylephrine HCl |