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NDC 63824-0056-72 Mucinex DM 30; 600 mg/1; mg/1 Details
Mucinex DM 30; 600 mg/1; mg/1
Mucinex DM is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. 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: 63824-0056-72Last Updated: 12/01/2022
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: 63824-0056-72Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 63824-0056 |
|---|---|
| Product ID | 63824-056_f3a9bb41-e44b-4d87-9133-19841cdfec5e |
| Associated GPIs | 43997002527430 |
| GCN Sequence Number | 012074 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan TAB ER 12H 600MG-30MG ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 53550 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Brand |
| Proprietary Name | Mucinex DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin and Dextromethorphan Hydrobromide |
| 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 | RB Health (US) LLC |
| 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 | NDA |
| Application Number | NDA021620 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63824-0056-72 (63824005672)
| NDC Package Code | 63824-056-72 |
|---|---|
| Billing NDC | 63824005672 |
| Package | 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-72) |
| Marketing Start Date | 2012-06-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 70987d06-d206-445f-bd0d-5e1345b8465c 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
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
INGREDIENTS AND APPEARANCE
| MUCINEX DM
guaifenesin and dextromethorphan hydrobromide tablet, extended release |
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| Labeler - RB Health (US) LLC (081049410) |
Revised: 6/2022
Document Id: f3a9bb41-e44b-4d87-9133-19841cdfec5e
Set id: 70987d06-d206-445f-bd0d-5e1345b8465c
Version: 15
Effective Time: 20220616