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NDC 70000-0464-01 Mucus Relief DM Extended Release Caplets 60; 1200 mg/1; mg/1 Details
Mucus Relief DM Extended Release Caplets 60; 1200 mg/1; mg/1
Mucus Relief DM Extended Release Caplets is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. 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: 70000-0464-01Last 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: 70000-0464-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 70000-0464 |
|---|---|
| Product ID | 70000-0464_55dad94f-71e8-4e1e-bd70-520033e6d8cd |
| 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 | Mucus Relief DM Extended Release Caplets |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin, Dextromethorphan HBr |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 60; 1200 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Cardinal Health (Leader) 70000 |
| 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 | ANDA |
| Application Number | ANDA209692 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0464-01 (70000046401)
| NDC Package Code | 70000-0464-1 |
|---|---|
| Billing NDC | 70000046401 |
| Package | 28 BLISTER PACK in 1 CARTON (70000-0464-1) / 1 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2018-12-31 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.56027 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | MUCUS RLF DM MAX ER 1200-60 MG |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 04af43e6-6276-42ec-a902-3de22bc9fdea 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
Warnings
Do not use
- for children under12 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
COMPARE TO MUCINEX® DM MAXIMUM STRENGTH active ingredients*
Maximum strength
Mucus Relief DM
Dextromethorphan HBr, 60 mg
Guaifenesin, 1200 mg
Cough Suppressant Expectorant
12 Hour Relief
Controls Cough
Thins and Loosens Mucus
EXTENDED-RELEASE TABLETS
*This product is not manufactured or distributed Reckitt Benckiser LLC, distributor Mucinex® DM Maximum Strength.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
INGREDIENTS AND APPEARANCE
| MUCUS RELIEF DM EXTENDED RELEASE CAPLETS
guaifenesin, dextromethorphan hbr tablet |
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| Labeler - Cardinal Health (Leader) 70000 (063997360) |