FDA Label for Mielim Y Mas
View Indications, Usage & Precautions
Mielim Y Mas Product Label
The following document was submitted to the FDA by the labeler of this product Efficient Laboratories 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
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. - if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.
Stop use and ask a doctor
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
Package Label.Principal Display Panel
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