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| Product NDC Code | 58593-276 | ||||
|---|---|---|---|---|---|
| Drug Name | Rompe pechito dm for kids |
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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 2.5 ml.) Purpose Dextromethorphan Hydrobromide 5 mg ...................................... Cough Suppressant Guaifenesin 50 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 Do not give more than 6 doses in any 24 hours period shake well before use measure only with dosing cup provided keep dosing cup with product mL = milliliter Age Dose Children 6 to under 12 years of age 5 mL every 4 hours Children 4 to under 6 years of age 2.5 mL every 4 hours Children under 4 years of age Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Inactive Ingredients: citric acid, elderberry fruit extract, glycerin, honey, maltodextrin, methylparaben, flavor, potassium sorbate as a preservative, propylparaben, propylene glycol, purified water, sodium chloride, sucralose 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 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 drain bronchial tubes.
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 Pechito DM for Kids Dextromethorphan HBr, Guaifenesin SUCRALOSE ANHYDROUS CITRIC ACID AMERICAN ELDERBERRY MALTODEXTRIN METHYLPARABEN HONEY POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CHLORIDE 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.Rompe Pechito Pack
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.Stop use and ask a doctor if cough that occurs with too much phlegm (mucus) persistent or chronic cough, such as occurs with asthma or chronic bronchitis. These could be signs of a serious condition.
Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough, such as occurs with asthma or chronic bronchitis
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 Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving 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 overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information store this product between 15 to 30 °C (59 to 86 °F ) do not refrigerate product color & flavor may vary due to natural honey Tamper-Evident Feature: do not use this product if printed security seal is torn, broken or missing.
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
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 in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving 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