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 |