Rompe Pecho Liquid
FDA Label NDC 58593-235

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 58593-235). 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, warnings, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, indications & usage, 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 HBr 10 mg ...................................... Cough Suppressant

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

Phenylephrine HCL  5 mg .................................................... Nasal Decongestant

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

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.

Otc - Do Not Use



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

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 consult a doctor 

Indications & Usage

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.

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


Distributed by

Efficient Laboratories, Inc., Miami, Fl 33166

Made in U.S.A.

Package Label.Principal Display Panel

Rompepechocf (Rpcfbox1)

Rompepechocf (Rpcfbox1)

Rpcfbogo (Rpcfbogo)

Rpcfbogo (Rpcfbogo)

* Please review the disclaimer below.