Facol Cold and Flu Night is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Jw Holdings. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide; Diphenhydramine Hydrochloride.
| Product ID | 69365-003_7bc70e7d-d7b9-78e8-e053-2991aa0ab40b |
| NDC | 69365-003 |
| Product Type | Human Otc Drug |
| Proprietary Name | Facol Cold and Flu Night |
| Generic Name | Acetaminophen, Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hbr, Diphenhydramine Hcl |
| Dosage Form | Capsule, Liquid Filled |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-08-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Labeler Name | JW HOLDINGS |
| Substance Name | ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE |
| Active Ingredient Strength | 200 mg/1; mg/1; mg/1; mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2015-08-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph not final |
| Application Number | part343 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2015-08-01 |
| Marketing Category | OTC monograph not final |
| Application Number | part343 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2015-08-01 |
| Marketing End Date | 2015-07-07 |
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 200 mg/1 |
| SPL SET ID: | 104a3cba-6eb2-48b3-e054-00144ff8d46c |
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