Head and Cold is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Hi-tech Nutraceuticals, Llc. The primary component is Acetaminophen; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide; Guaifenesin.
| Product ID | 69732-003_a45bf0fd-8714-0443-e053-2995a90a4743 |
| NDC | 69732-003 |
| Product Type | Human Otc Drug |
| Proprietary Name | Head and Cold |
| Generic Name | Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-04-30 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | Hi-Tech Nutraceuticals, LLC |
| Substance Name | ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Active Ingredient Strength | 325 mg/1; mg/1; mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-04-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-04-30 |
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 69732-003 | Head and Cold | acetaminophen, guaifenesin, dextromethorphan HBr, phenylephrine HCl |
| 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 |