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NDC 70000-0372-01 Leader Mucus DM 60; 1200 mg/1; mg/1 Details
Leader Mucus DM 60; 1200 mg/1; mg/1
Leader Mucus DM is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. 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: 70000-0372-01Last 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: 70000-0372-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 70000-0372 |
|---|---|
| Product ID | 70000-0372_e61d17e0-8113-4c17-8628-a8e38d22312b |
| Associated GPIs | 43997002527475 |
| GCN Sequence Number | 042105 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan TAB ER 12H 1200-60MG ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 93677 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Leader Mucus DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dextromethorphan HBr, guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 60; 1200 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Cardinal Health 110, LLC. dba Leader |
| 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 | ANDA207602 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0372-01 (70000037201)
| NDC Package Code | 70000-0372-1 |
|---|---|
| Billing NDC | 70000037201 |
| Package | 1 BOTTLE in 1 CARTON (70000-0372-1) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| Marketing Start Date | 2018-05-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 73f9e9c8-3319-4916-a897-8db06e34562a Details
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
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
Stop use and ask a doctor if
Keep out of reach of children.
Directions
Other information
Inactive ingredients
Package/Label Principal Display Panel
Maximum Strength
Mucus-DM
Guaifenesin, 1200 mg
Dextromethorphan Hydrobromide, 60 mg
Extended-Release Tablets
Expectorant | Cough Suppressant
12 Hour
COMPARE TO MAXIMUM STRENGTH MUCINEX® DM active ingredients
Controls Cough
Thins and Loosens Mucus
100% Money Back Guarantee
28 EXTENDED-RELEASE TABLETS
Actual Size
INGREDIENTS AND APPEARANCE
| LEADER MUCUS DM
dextromethorphan hbr, guaifenesin tablet, extended release |
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| Labeler - Cardinal Health 110, LLC. dba Leader (063997360) |