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| Product NDC Code | 58593-235 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Rompe pecho cf |
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| Type | Brand | ||||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 1044949 | ||||||||
| 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 HBr 10 mg ...................................... Cough Suppressant Guaifenesin 100 mg ................................................................... Expectorant Phenylephrine HCL 5 mg .................................................... Nasal Decongestant
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 consult a doctor
| 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 | consult a doctor |
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, 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 temporarily relieves cough and nasal congestion 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 Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Rompe Pecho CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL SUCRALOSE HOREHOUND CAULOPHYLLUM THALICTROIDES ROOT ECHINACEA, UNSPECIFIED EUCALYPTUS GLOBULUS LEAF GINKGO GOLDENSEAL HONEY GLYCYRRHIZA GLABRA MENTHOL METHYLPARABEN VERBASCUM DENSIFLORUM LEAF MYRRH POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER ULMUS RUBRA BARK SODIUM CHLORIDE PRUNUS SEROTINA BARK ZINC SULFATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE
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 RPCFBogo
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.Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • a persistant or chronic cough a cough that is accompanied by excessive phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema. Stop use and ask doctor if symptoms do not improve within 7 days or is accompanied by a fever, rash, or persistent headache. A persistent cough may be sign of a serious condition. nervousness, dizziness, or sleeplessness occurs
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 Distributed by Efficient Laboratories, Inc., Miami, Fl 33166 Made in U.S.A.
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. Do not use If you are 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 your 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