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| Product NDC Code | 72090-027 | ||||
|---|---|---|---|---|---|
| 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 | 1147685 | ||||
| Application Number | M012 | ||||
| Labeler Name | Pioneer Life Sciences, 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 tablet) Dextromethorphan HBr 20 mg Guaifenesin 400mg
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 older: Take 1 tablet every 4 hours with a full glass of water. Do not exceed 6 doses in 24 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: microcrystalline cellulose, sodium starch glycolate, stearic acid powder, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, D&C yellow
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) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves o cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants o the intensity of coughing o the impulse to cough to help you get to sleep
Purpose
Information about the drug product’s indications for use.Purpose Dextromethorphan HBr 20 mg ......................................... Cough suppressant Guaifenesin 400mg ........................................................................ Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Mucus Relief DM Dextromethorphan HBr 20mg Guaifenesin 400mg DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN microcrystalline cellulose SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED D&C YELLOW NO. 10 ALUMINUM LAKE ET16
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.PL0126 - Mucus Relief DM 200ct-Elysium 08.09.2023
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.OTHER INFORMATION: Store between 20ºC-25ºC (68ºF-77ºF). Keep in a dry place and do not expose to heat do not use if imprinted safety seal under cap is broken or missing.
This product is not manufactured or distributed by Reckitt Benckiser’s, owner of the registered trademark MUCINEX DM ® Tablets.
Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln, Suite A, East Brunswick, NJ 08816
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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough accompanied by too much phlegm (mucus)
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 for children under 12 year 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.
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 (1-800-222-1222).
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? Call (732) 698-5070 Monday through Friday 9 AM to 5 PM EST or www.pioneerlifesciences.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 more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be sign of serious illness.
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 use more than directed
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:
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