FDA Label for Berro Y Cebolla DM

View Indications, Usage & Precautions

Berro Y Cebolla DM Product Label

The following document was submitted to the FDA by the labeler of this product Menper Distributors, 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.

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 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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