FDA Label for Childrens Giltuss Honey Dm Cough
View Indications, Usage & Precautions
Childrens Giltuss Honey Dm Cough Product Label
The following document was submitted to the FDA by the labeler of this product Dextrum 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 - Keep Out Of Reach Of Children
in case of overdose, get medical help or contact a Poison Control Center right away
Indications & Usage
Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product
children under 4 years, consult a doctor
children 6 to under 12 years, 5ml every 6-8 hours
children 12 years and over, 10ml every 6-8 hours
Otc - Active Ingredient
Active ingredient (in each 5ml)
Active Ingredients ( in each 5 mL)
Dextromethorphan15mg
purpose cough suppresant
Warnings
Do not use if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fotdepression, psychriatic or emotional condition, orParkinso's desese), or for 2 weeksafter stoppings the MAOI drugs. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - Stop Use
Stop use and ask a doctorif the child has a cough that last more than 7 days, comes back or is accompanied byfever, rash or persistent headache. These could be signs of a serius condition.
Otc - Purpose
Purpose section Cough Suppresant
Otc - Ask Doctor
Ask a doctor before use if the child has couhg that occurs with too muchmucus
a persistent or chronic cough such as occurs with sthma.
Other Safety Information
Temporarily relieves: cough due to minor thoroat and brochial irritation associated with the common cold or inhaled irritants
the intensity of coughing
The impulse to cough to help your child get to sleep
Otc - Questions
Call 1-787-848-9114 Monday-Friday, 9AM-5PM EST
Call your doctor for medeical advice in the event of side effects.
Dosage And Administration
Dosage and administration
Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product
children under 4 years, consult a doctor
children 6 to under 12 years, 5ml every 6-8 hours
children 12 years and over, 10ml every 6-8 hours
Inactive Ingredient
Inactive ingredients:
Natural and artificial flavor, natural grade A Honey, Methylparaben, potassium Sorbate, propylene Glycol, propylparaben, purified water, sucralose
Principal Display Panel
Children giltuss honey DM 4-12
Alcohol Free
DYE free
Non Drowsy
Certified Honey
Honey Lemon Flavor
* Please review the disclaimer below.
