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  5. Label Information: Limpia Pecho

FDA Label for Limpia Pecho

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. PREGNANCY
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. OTC - QUESTIONS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Limpia Pecho Product Label

The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical International Division, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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