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| Product NDC Code | 58593-275 | ||||
|---|---|---|---|---|---|
| Drug Name | Rompe pecho 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 | LIQUID | ||||
| RxCUI drug identifier | 996520 | ||||
| Application Number | M012 | ||||
| Labeler Name | Efficient Laboratories Inc | ||||
| 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 Ingredients: (in each teaspoonful 5 ml.) Purpose Dextromethorphan Hydrobromide 10 mg ...................................... Cough Suppressant Guaifenesin 100 mg ................................................................... Expectorant
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 Shake well before use Do not exceed more than 6 doses in any 24 hour period or as directed by a doctor Age Dose Adults and Children 12 years of age and over 10 mL (2 tsps.) every 4 hours Children 6 to under 12 years of age 5 mL (1 tsp.) every 4 hours Children under 6 years of age Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Blue Cohosh root extract, Echinacea root extract, Eucalyptus oil, Gingka Biloba leaf extract, glycerin, Golden Seal Root extract, Honey, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Pleurisy Root, Potassium sorbate, polysorbate 80, propolis extract, propylene glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Spearmint flavor, Sucralose, water, Wild Cherry Bark extract and Zinc Sulfate.
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 as may occur with the common cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.
Purpose
Information about the drug product’s indications for use.Purpose Cough Suppressant Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Rompe Pecho DM Dextromethorphan HBr, Guaifenesin SUCRALOSE PROPOLIS WAX CAULOPHYLLUM THALICTROIDES ROOT ECHINACEA, UNSPECIFIED EUCALYPTUS GLOBULUS LEAF GINKGO GOLDENSEAL HONEY GLYCYRRHIZA GLABRA MENTHOL METHYLPARABEN VERBASCUM DENSIFLORUM LEAF MYRRH ASCLEPIAS TUBEROSA ROOT POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER ULMUS RUBRA BARK SODIUM CHLORIDE SPEARMINT PRUNUS SEROTINA BARK ZINC SULFATE GLYCERIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN
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.box
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 on MAOI, ask a doctor or pharmacist before taking this product. Stop use and ask a doctor If cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
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? 305-805-3456 Monday - Friday 9AM to 5PM EST www.efficientlabs.com
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 exceed recommended dosage. Ask a doctor before use if you have a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
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