Rompe Pecho Liquid
FDA Label NDC 58593-275

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 58593-275). 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

Dextromethorphan Hydrobromide 10 mg ...................................... Cough Suppressant

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

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Indications & Usage

Uses:

  • temporarily relieves cough as may occur with the common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.

Warnings

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Otc - Do Not Use

Do not use

  • if you are now 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 on MAOI, ask a doctor or pharmacist before taking this product.  

    • Stop use and ask a doctor
    • If cough persists 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 accidental 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 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                                     Do not use

Inactive Ingredient

Inactive Ingredients: Blue Cohosh root extract, Echinacea root extract, Eucalyptus oil, Gingka Biloba leaf extract, glycerin, Golden Seal Root extract, Honey, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Pleurisy Root, Potassium sorbate, polysorbate 80, propolis extract, propylene glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Spearmint flavor, 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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