Berro Y Cebolla Liquid
FDA Label NDC 53145-080

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc. for the product Berro Y Cebolla (NDC 53145-080). 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 active ingredients in each 15ml, purpose, uses, do not exceed recommended dosage, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients In Each 15Ml

Dextromethorphan HBr - 10mg

Guaifenesin - 100mg

Purpose

Cough Suppressant

Expectorant

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

Do Not Exceed Recommended Dosage

Do not use

if you are now taking a prescription monamine 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.

Ask A Doctor Before Use If You Have

a persistent or chronic cough
a cough that is accompanied by excessive phlegm (mucus)
a breathing problem such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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. A persistent cough may be a sign of a serious condition
  • nervousness, dizziness, or sleeplessness occurs

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children.

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

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                             2 tablespoons (30 mL) every 4 hours
children 6 to under 12 years of age                                           1 tablespoon (15 mL) every 4 hours
children under 6 years of age                                                   consult a doctor

Other Information

store between 15° - 30° C (59° - 86° F)

Tamper-Evident Feature: Do not use this product if printed safety seal over cap is torn, broken or missing.

Inactive Ingredients

Aloe leaf extract, ascorbic acid, cat's claw bark extract, corn syrup, DATEM, ethyl alcohol (0.15%), eucalyptus, FD&C blue #1, FD&C yellow #5, garlic bulb extract, ginger root extract, gum arabic, honey, menthol, methylparaben, onion bulb fluid extract, peppermint leaf fluid extract, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium benzoate, sucralose, sunflower oil, water.

Questions Or Comments?

1-800-560-5223 M-F 9 AM to 4 PM Eastern

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