Otc - Active Ingredient
Active Ingredients ( in each 5 mL)
Dextromethorphan HBr , 15 mg
Guaifenesin, 300 mg
Phenylephryne HCl, 10 mg
Giltuss Cough And Cold Solution
FDA Label NDC 65852-012
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 Cough And Cold (NDC 65852-012). 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 - active ingredient, purpouse section & uses, warnings, ask a doctor, ask a doctor or pharmacist, stop use, pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpouse Section & Uses
Cough supressant
Expectorant
Nasal Descongestant
Uses
temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive, temporary relieves nasal congestion due to a cold.
Warnings
Warnings
Do not use if you are now taking a prescription monoamine oxidase inhibitor ( MAOI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you dont know if 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, heart disease, high blood pressure, thryroid disease, diabetes, or difficulty in urination due to enlargement of the prostate unless directed by a doctor, cough with too much phlegm ( mucus), a persistent or chronic cough as occurs with smoking, asthma,chronic bronchitis, or ephysema
Ask A Doctor Or Pharmacist
Ask a doctor o pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives , tranquilizer, and drugs used for depression, especially monoamine oxidase inhibitors (MAOI's)
Stop Use
Stop use and ask a doctor if, nervousness, dizziness, or sleeplessness occur, sympton do not get better within 7 days or are accompanied by fever, cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These can be signs of a serious condition.
Pregnancy Or Breast Feeding
Pregnancy 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 Poison 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 for use with this product, ml=mililiters.
Adults and children 12 years & over 5 ml every 4 hours
children 6 to under 12 years age 2.5 ml every 4 hours
children 4 to 6 years of age 1.25 ml every 4 hours
children under 6 years of age Consult a doctor
Other Information
Other information
Store at room temperature , between 15-30 oC
Keep thigtly closed
Save carton for complete drug facts
Questions
Questions
Call 1-787-848-9114, Monday-Friday 9 AM --5PM EST
Call your doctor for medical advice in the event of side effects.
Keep Out Of Reach Of Children
Keep out of reach of children section
In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediatly.
Indication And Usage Section
Indication and usage section
Do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.
Adults and children 12 years & over 5 ml every 4 hours
children 6 to under 12 years age 2.5 ml every 4 hours
children 4 to 6 years of age 1.25 ml every 4 hours
children under 6 years of age Consult a doctor
Principal Panel
maximun strength
Giltuss Cold & cold
Alcohol free
Sugar free
Dye free
Cough, Phlem & Stuffy nose
Non-drowsy
Cherry flavor
4 flox 118 ml
* Please review the disclaimer below.
