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NDC 57237-0312-51 Dextromethorphan HBr. and Guaifenesin 10; 100 mg/5mL; mg/5mL Details
Dextromethorphan HBr. and Guaifenesin 10; 100 mg/5mL; mg/5mL
Dextromethorphan HBr. and Guaifenesin is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Rising Pharma Holdings, Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 57237-0312-51Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 57237-0312-51Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 57237-0312 |
|---|---|
| Product ID | 57237-312_89958dcf-99cf-4c41-bc16-480e87e02eee |
| Associated GPIs | |
| GCN Sequence Number | 000652 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 100-10MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 53491 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Dextromethorphan HBr. and Guaifenesin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan HBr. and Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 10; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Rising Pharma Holdings, Inc. |
| Pharmaceutical Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 57237-0312-51 (57237031251)
| NDC Package Code | 57237-312-51 |
|---|---|
| Billing NDC | 57237031251 |
| Package | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-312-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-312-05) |
| Marketing Start Date | 2023-06-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |