Rompe Pecho Liquid
FDA Label NDC 58593-829

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Efficient Laboratories Inc for the product Rompe Pecho (NDC 58593-829). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:(in each teaspoonful 5 ml.)                                Purpose

Guaifenesin 100 mg ................................................................... Expectorant

Otc - Purpose

Purpose

Expectorant

Indications & Usage

Uses:

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.

Warnings

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)

Otc - Do Not Use

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

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

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.

Otc - Questions

Questions or Comments?

305-805-3456 Monday - Friday 9AM to 5PM EST

www.efficientlabs.com

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