FDA Label for Rompe Pechito Dm For Kids
View Indications, Usage & Precautions
Rompe Pechito Dm For Kids 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 Ingredients:(in each teaspoonful 2.5 ml.) Purpose
Dextromethorphan Hydrobromide 5 mg ...................................... Cough Suppressant
Guaifenesin 50 mg ................................................................... Expectorant
Otc - Purpose
Purpose
Cough Suppressant
Expectorant
Uses
Uses:
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Warnings
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
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.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
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:
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.
Otc - Questions
Questions or Comments?
305-805-3456 Monday - Friday 9AM to 5PM EST
www.efficientlabs.com
Stop Use And Ask A Doctor If
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.
Ask A Doctor Before Use If The Child Has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough, such as occurs with asthma or chronic bronchitis
Other Information
- store this product between 15 to 30 °C (59 to 86 °F )
- do not refrigerate
- product color & flavor may vary due to natural honey
Tamper-Evident Feature: do not use this product if printed security seal is torn, broken or missing.
* Please review the disclaimer below.