Active Ingredients
Active Ingredients ( in each 10 ml)
Dextromethorphan, 30 mg
Giltuss Honey Dm Cough Solution
FDA Label NDC 65852-004
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 Giltuss Honey Dm Cough (NDC 65852-004). 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 active ingredients, purpose and uses, warning, ask a doctor, stop use, if pregnant, indication and usage section, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose And Uses
Purpose
Cough supresant
Uses
Temporary relieves:
Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, the intensity of coughing ,the impulse to cough to help you get sleep,
Warning
Warnings
Do not use
If you are taking a prescription monoamine oxidase inhibitor (MAOI) ( certains drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you dont know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor
Ask a doctor before use if you have, a cough with too much phlegm (mucus) , a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Stop Use
Stop use and ask a doctor if
cough lasts for more than 7 days , come back, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition.
If Pregnant
If pregnant or breast- feeding, ask a health professional before use. Keep out of reach of children.
In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately
Indication And Usage Section
Do not take more than 4 doses in any 24 hours period
Use enclosed dosing cup
Keep dosing cup for use with this product
ml= mililiters
Adults and children 12 years & over 10 ml every 6-8 hours
children 6 to under 12 years of age 5 ml every 6-8 hours
children 4 to under 6 years of age 2.5 ml every 6-8 hours
children under 4 years of age Consult a doctor
Other Information
Other information
Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS
Inactive Ingredients
Inactive ingredients
natural and artificial flavor, natural grade A honey, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose
Dosage
Dosage and administration
Do not take more than 4 doses in any 24 hours period
Use enclosed dosing cup
Keep dosing cup for use with this product
ml= mililiters
Adults and children 12 years & over 10 ml every 6-8 hours
children 6 to under 12 years of age 5 ml every 6-8 hours
children 4 to under 6 years of age 2.5 ml every 6-8
Keeo Out Of The Reach Of Children.
Keeo out of the reach of children.
in case of overdose, get medical help or contact a Poison Control Center right away.
Principal Panel
Maximum strength
Alcohol free, dye free, Non-Drowsy
The source Cerified Honey
Giltus Honey DM
Cough
Dextromethorphan HBr, 30 mg
Persistent Cough
Up to 8 hours
Honey lemon flavor
4 floz 118 ml
* Please review the disclaimer below.
