Cough and Cold XL3 Xtra is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Progela, S.a. De C.v.. The primary component is Acetaminophen; Phenylephrine Hydrochloride; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide.
| Product ID | 28623-250_78879103-1247-035c-e053-2991aa0a1784 |
| NDC | 28623-250 |
| Product Type | Human Otc Drug |
| Proprietary Name | Cough and Cold XL3 Xtra |
| Generic Name | Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride |
| Dosage Form | Capsule, Liquid Filled |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-03-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | Progela, S.A. de C.V. |
| Substance Name | ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE |
| Active Ingredient Strength | 250 mg/1; mg/1; mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2013-03-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2013-03-01 |
| Marketing End Date | 2018-10-15 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-08-22 |
| Marketing End Date | 2020-01-01 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2018-10-15 |
| Marketing End Date | 2020-01-01 |
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/1 |
| SPL SET ID: | 1d878c3c-dd0e-4024-ac98-7053748d164b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 28623-250 | Cough and Cold | Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride |
| 58596-001 | Cough and Cold | Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride |
| 63654-800 | Cough and Cold | Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride |
| 76095-015 | Cough and Cold | Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride |