Limpia Pecho Liquid
FDA Label NDC 54859-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division, Inc. for the product Limpia Pecho (NDC 54859-011). 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, pregnancy, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

In each teaspoonful, 5 mL

Dextromethorphan HBr - 10 mg

Guaifenesin - 100 mg

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

Do not use

  • if you are now taking a 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 a doctor or pharmacist before taking this prduct.

    • 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.

      • Stop use and ask a dotor if

      • cough persist for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These may be signs of a serious condition

Pregnancy

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

  • use dosage cup provided
  • Do not exceed 6 doses in any 24 hour period or as directed by a doctor
    •  Age Dose
     Adults and children over 12 years of age 10 mL (2 tsp) every 4 hours
     Children 6 to under 12 years of age 5 mL (1 tsp) every 4 hours
     Children under 6 Ask a doctor

Inactive Ingredient

Inactive ingredients artificial and natural flavor, citric acid, methol, methylparaben, propylened glycol, propylparaben, purified water, sodium citrate, and sucralose.

Otc - Questions

Questions or Comments? 1-866-595-5598

Package Label.Principal Display Panel

Lipiapecho (Limpiapecho)

Lipiapecho (Limpiapecho)

* Please review the disclaimer below.