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| Product NDC Code | 58593-829 | ||||||
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| Drug Name | Rompe pecho ex |
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| Type | Brand | ||||||
| Pharm Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| 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 Guaifenesin 200 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 exceed more than 6 doses in any 24 hour period mL=milliliter this adult product is not intended for use in children under 12 years Age Dose adults and children 12 years and over 10 mL (2 teaspoonful) every 4 hours children under 12 years of age do not use
| Age | Dose |
| adults and children 12 years and over | 10 mL (2 teaspoonful) 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: Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal Root extract, Honey, Horehound (flower, leaf, stem) extract, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Potassium Sorbate, Propylene glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride,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: Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.
Purpose
Information about the drug product’s indications for use.Purpose Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Rompe Pecho EX Guaifenesin GLYCERIN SUCRALOSE 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 PRUNUS SEROTINA BARK ZINC SULFATE HOREHOUND 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.label 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.Stop use and ask a doctor if cough persists for 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 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 each 10 mL contains: potassium 5 mg store between 15° - 30°C (59° - 86°F). Do not refrigerate product color & flavor may vary due to natural honey TAMPER - EVIDENT FEATURE: Do not use this product if printed safety seal over cap 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) or 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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
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