Otc - Keep Out Of Reach Of Children
in case of overdose, get medical help or contact a Poison Control Center right away
Childrens Giltuss Honey Dm Cough Liquid
FDA Label NDC 65852-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories Inc for the product Childrens Giltuss Honey Dm Cough (NDC 65852-007). 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 otc - keep out of reach of children, indications & usage, otc - active ingredient, warnings, otc - stop use, otc - purpose, otc - ask doctor, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Children Under (Dosage)
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 (Warnings.)
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 (Purpose)
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
Temporary (Use)
the intensity of coughing
The impulse to cough to help your child get to sleep
Otc - Questions
Call (Question)
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
Chid Giltuss Honey Dm Panel (Panel)
Alcohol Free
DYE free
Non Drowsy
Certified Honey
Honey Lemon Flavor
* Please review the disclaimer below.
