Active Ingredients
Active ingredients
Dextromethorpan HBr, 20 mg
Guafenesin , 200 mg
Giltuss Diabetic Solution
FDA Label NDC 65852-009
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 Diabetic (NDC 65852-009). 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 & uses section, warnings, ask a doctor, stop use and ask a doctor if, if pregnant or breast- feeding, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose & Uses Section
Purposes
Cough suppresant
Expectorant
Uses
temporary relieves, cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, the intensity of coughing, the impulse to cough to help you get to sleep, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes.
Warnings
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, when using this product do not use more than directed.
Stop Use And Ask A Doctor If
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 Or Breast- Feeding
If pregnant or breast- feeding, ask a health professional before use. Keep out of reach of childen. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediatly
Directions
Directions
Do not exceed recommended dosage
Do not take more than 6 doses in any 24 hours period
Keep dosing cup with product
ml= mililiters
Adults and children 12 years & over 10 ml every 4 hours
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 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
I
Questions Or Comments?
Questions or comments?
Call 1-787-848-9114, Monday-Friday 9AM-5PM EST, Call your doctor for medical advice in the event of side effects.
Label revised :06/22
Indication And Usage Section
Indication and usage section
Do nor exceed recommended dosage
Do not take more than 6 doses in any 24 hours period
Adults and children 12 years and over 10 ml every 4 hours
Children 6 to under 12 years age 5 ml every 4 hours
Children 4 to under 6 years age 2.5 ml every 4 hours
Children under 4 years of age Consult a doctor
Keep Out Of Reach Of Childen.
Keep out of reach of childen.
In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediatly
Package Label.Principal Display Panel
Giltuss Diabetic
Cough & Cold
Sugar Free, Alcohol free, Sorbitol free, Sodium free
Dye free, Fructose free, Gluten free, Non -Drowsy
Cough & Cold, Chest congestion, liquifies and loosens Phlegm and mucus
Safe for people with diabetes
4 floz 118 ml
Rasperry flavor
* Please review the disclaimer below.
