Mielim Y Mas Liquid
FDA Label NDC 58593-295

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 Mielim Y Mas (NDC 58593-295). 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 - keep out of reach of children, otc - pregnancy or breast feeding, 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 Ingredient: (In each teaspoonful 5 mls)                   Purpose

Dextromethorphan HBr 15 mg (USP)................................................Cough Suppressant

Otc - Purpose

Cough Suppressant

Warnings

Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Otc - Do Not Use

Do not use

  • this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • 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 an MAOI,
    ask a doctor or pharmacist before taking this product.

    • Stop use and ask a doctor

    • if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact the Poison Control Center right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Dosage & Administration

Directions:

Shake well immediately before use.

Do not exceed 4 doses in any 24 hour period.

Adults and Children 12 years and over - 10 ml (2 tsps) every 6 to 8 hours

Children 6 to under 12 years of age - 5 ml (1 tsp) every 6 to 8 hours

Children under 6 years of age - Consult a doctor

Indications & Usage

Temporarily relieves cough as may occur with the common cold or inhaled irritants.

Inactive Ingredient

Inactive Ingredients: Aspartame, Flavor, Honey,
Methylparaben, Potassium Sorbate, Propylene
Glycol, Propylparaben, Purified Water and Sodium
Chloride.

Otc - Questions

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com


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Mielim (Mielimymas2)

Mielim (Mielimymas2)

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