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Rompe pecho ex - Medication Information

Product NDC Code 58593-829
Drug Name

Rompe pecho ex

Type Brand
Pharm Class Decreased Respiratory Secretion Viscosity [PE],
Expectorant [EPC],
Increased Respiratory Secretions [PE]
Active Ingredients
Guaifenesin 100 mg/5ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 310604,
1112205
Application Number M012
Labeler Name Efficient Laboratories Inc
Packages
Package NDC Code Description
58593-829-04 118 ml in 1 bottle (58593-829-04)
58593-829-06 178 ml in 1 bottle (58593-829-06)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients: (in each teaspoonful 5 ml.) Purpose 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 and over 10 mL (2tsps) every 4 hrs. children 6 to under 12 years of age 5 mL (1 tsp) every 4 hrs 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: 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 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.

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 feeding
If 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