Cold Medicine XL3 FORTE is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Midway Importing Inc.. The primary component is Acetaminophen; Chlorpheniramine Maleate; Phenylephrine Hydrochloride.
| Product ID | 76095-010_8140655a-71d2-757c-e053-2a91aa0a259a |
| NDC | 76095-010 |
| Product Type | Human Otc Drug |
| Proprietary Name | Cold Medicine XL3 FORTE |
| Generic Name | Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-08-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | MIDWAY IMPORTING INC. |
| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
| Active Ingredient Strength | 325 mg/1; mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2018-02-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2018-02-01 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2018-10-18 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-08-01 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-08-01 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2018-02-01 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2018-10-18 |
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| SPL SET ID: | 58252f15-485c-3061-e053-2a91aa0a2320 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 58596-002 | Cold Medicine | Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride |
| 63654-600 | Cold Medicine | Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride |
| 63654-601 | Cold Medicine | Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride |
| 63654-605 | Cold Medicine | Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride |
| 76095-010 | Cold Medicine | Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride |
| 76095-011 | Cold Medicine | Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride |