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NDC 51660-0301-41 Guaifenesin and Dextromethorphan HBr 30; 600 mg/1; mg/1 Details
Guaifenesin and Dextromethorphan HBr 30; 600 mg/1; mg/1
Guaifenesin and Dextromethorphan HBr is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by OHM LABORATORIES 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: 51660-0301-41Last Updated: 11/30/2022
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: 51660-0301-41Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 51660-0301 |
|---|---|
| Product ID | 51660-301_eb963e6d-d883-41dd-96ed-5284d105a8f4 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Guaifenesin and Dextromethorphan HBr |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin and Dextromethorphan HBr |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 30; 600 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | OHM LABORATORIES INC |
| Pharmaceutical Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214781 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51660-0301-41 (51660030141)
| NDC Package Code | 51660-301-41 |
|---|---|
| Billing NDC | 51660030141 |
| Package | 2 BLISTER PACK in 1 CARTON (51660-301-41) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2021-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f2eb5494-2672-444f-afa3-d1ef8ed1eaa1 Details
SPL UNCLASSIFIED SECTION
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
Warnings
Do not use
- for children under 12 years of age
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
Directions
- do not crush, chew, or break extended-release tablet
- take with a full glass of water
- this product can be administered without regard for timing of meals
- adults and children 12 years and older: 1 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
- children under 12 years of age: do not use
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 40 Tablet Blister Pack Carton
INGREDIENTS AND APPEARANCE
| GUAIFENESIN AND DEXTROMETHORPHAN HBR
guaifenesin and dextromethorphan hbr tablet, extended release |
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| Labeler - OHM LABORATORIES INC (184769029) |
| Registrant - SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | 650456002 | MANUFACTURE(51660-301) | |
Revised: 8/2021
Document Id: eb963e6d-d883-41dd-96ed-5284d105a8f4
Set id: f2eb5494-2672-444f-afa3-d1ef8ed1eaa1
Version: 2
Effective Time: 20210830