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| Product NDC Code | 68210-4153 | ||||
|---|---|---|---|---|---|
| Drug Name | Mucus relief dm |
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| Type | Brand | ||||
| Pharm 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 Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1661740 | ||||
| Application Number | M012 | ||||
| Labeler Name | Spirit Pharmaceuticals LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each softgel) Purposes Guaifenesin 400mg Expectorant Dextromethorphan HBr 20mg Cough Suppressant
| Guaifenesin 400mg | Expectorant |
| Dextromethorphan HBr 20mg | Cough Suppressant |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 years of age and over: take 1 softgel every 4 hours children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose
Information about the drug product’s indications for use.Active ingredient (in each softgel) Purposes Guaifenesin 400mg Expectorant Dextromethorphan HBr 20mg Cough Suppressant
| Guaifenesin 400mg | Expectorant |
| Dextromethorphan HBr 20mg | Cough Suppressant |
Spl product data elements
Usually a list of ingredients in a drug product.MUCUS RELIEF DM GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL SORBITAN TITANIUM DIOXIDE GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN LOGHT YELLOW OBLONG 440;901
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Mucus relief DM Dextromethorphan HBr 20 mg- cough suppressant Guaifenesin 400 mg - expectorant • Controls Cough • Thins & Loosens Mucus 10 Softgels image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask Doctor before use if you have cough accompanied by excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use 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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of Reach of Children In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-888-333-9792
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not exceed recommended dosage do not use for more than 7 days
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 25°C (77°F); excursions permitted between 15°- 30°C (59° - 86°F) keep in a dry place and do not expose to heat
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use 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 Doctor before use if you have cough accompanied by excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema When using this product do not exceed recommended dosage do not use for more than 7 days Stop use and ask a doctor if cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding ask a health professional before use Keep Out of Reach of Children In case of accidental overdose, get medical help or contact a Poison Control Center right away. Directions do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 years of age and over: take 1 softgel every 4 hours children under 12 years of age: do not use
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API