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Product NDC Code | 69517-120 | ||||
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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 | TABLET | ||||
RxCUI drug identifier | 1861926 | ||||
Application Number | M012 | ||||
Labeler Name | Healthlife of USA LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Guaifenesin 400mg Dextromethorphan HBr 15mg
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 Adults and children 12 years of age and over: Take 1 Tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under 12 years: Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Colloidal silicon dioxide Magnesium stearate Microcrystalline Cellulose Sodium starch glycolate
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 Helps loosen phlegm (mucus) Helps thin bronchial secretions to make coughs more productive Temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold
Purpose
Information about the drug product’s indications for use.Drug Facts Immediate Release Mucus Relief DM
Purpose Expectorant, Cough Suppressant
Spl product data elements
Usually a list of ingredients in a drug product.Mucus Relief DM Guaifenesin, Dextromethorphan HBr Tablets SILICON DIOXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A CORN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN
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.Immediate Release Mucus Relief DM Guaifenesin 400mg / Expectorant Dextromethorphan HBr 15 mg/ Cough Suppressant Controls Cough Thins and Loosens Mucus 12 Tablets Distributed by: Healthlife of USA LLC Rahway NJ 07065 www.healthlifeofusa.com image description
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 a doctor before use if you have Persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema Cough accompanied by excessive phlegm (mucus)
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are Taking sedatives or Tranquilizers
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 overdosage, 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.Other Information Each Tablet contains: sodium 1.24 mg VERY LOW SODIUM store at 25°C (77°F) excursions between 15°-30°C (59°-86°F) Keep in a dry place and do not expose to heat Read all product information before using TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Questions or comments? Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com
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 persistant 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 ot use for more than 7 days
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, Ask a health professional before use.
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 prescriprion 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.
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