The following Structured Product Label (SPL) was submitted to the FDA by Efficient Laboratories Inc for the product Rompe Pechito (NDC 58593-276). 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, uses, warnings, do not use, keep out of reach of children., directions, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients:(in each teaspoonful 2.5 ml.) Purpose
Dextromethorphan Hydrobromide 5 mg ...................................... Cough Suppressant
Guaifenesin 50 mg ................................................................... Expectorant
Purpose
Cough Suppressant
Expectorant
Uses:
Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
In case of overdose, get medical help or contact a Poison Control Center right away.
Do not give more than 6 doses in any 24 hours period shake well before use measure only with dosing cup provided keep dosing cup with product mL = milliliter
Age Dose
Children 6 to under 12 years of age 5 mL every 4 hours
Children 4 to under 6 years of age 2.5 mL every 4 hours
Children under 4 years of age Do not use
Inactive Ingredients: citric acid, elderberry fruit extract, glycerin, honey, maltodextrin, methylparaben, flavor, potassium sorbate as a preservative, propylparaben, propylene glycol, purified water, sodium chloride, sucralose and zinc sulfate.
Questions or Comments?
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cough that occurs with too much phlegm (mucus)
persistent or chronic cough, such as occurs with asthma or chronic bronchitis.
These could be signs of a serious condition.
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