Night Time Gelcap is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Kareway Product, Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.
| Product ID | 67510-0521_9ea99d30-2c01-4899-8557-55ff3710818d |
| NDC | 67510-0521 |
| Product Type | Human Otc Drug |
| Proprietary Name | Night Time Gelcap |
| Generic Name | Acetaminophen, Dextromethorphan, Doxylamine |
| Dosage Form | Capsule, Liquid Filled |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-06-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | Kareway Product, Inc. |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
| Active Ingredient Strength | 325 mg/1; mg/1; mg/1 |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2011-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-06-01 |
| Inactivation Date | 2019-11-27 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-06-01 |
| Inactivation Date | 2019-11-27 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-06-01 |
| Inactivation Date | 2019-11-27 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-06-01 |
| Inactivation Date | 2019-11-27 |
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| SPL SET ID: | 6b9b3de7-58cc-4b15-8e6e-6751ef40bc55 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 67510-0521 | Night Time Gelcap | Acetaminophen, Dextromethorphan, Doxylamine |
| 69517-103 | NightTime Cold and Flu Relief | Acetaminophen, Dextromethorphan, Doxylamine |