Giltuss Childrens Cough and Cold
Children's Giltuss Cough & Cold
3f025ef6-79e7-e833-e063-6294a90ab501
HUMAN OTC DRUG LABEL
Sep 17, 2025
Dextrum Laboratories Inc.
DUNS: 007392322
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal panel
Childrens 4-12
Cough & Cold
Alcohol free
Sugar free
Dye free
Non -Drowsy
Cherry Flavor
INDICATIONS & USAGE SECTION
Indication and Usage section
Indication and Usage section
no take more than 6 doses in any 24 hours period
use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter
Children under 4 years ----Consult a doctor
children 4 to under 6 years------1.25 ml every 4 hours
children 6 to under 12 years-----2.5 ml every 4 hours
children 12 yeras and over -------5 ml every 4 hours
WARNINGS SECTION
Warnings
Donot use if your child is now taking a prescription monoamine oxidase
inhibitor (MAOI) ( certain drugs for deppresion, psychiatric, or emotional
conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI
drug. If you do not know if your's child's prescription drug contains an MAOI,
ask a doctor or pharmacist before taking this
oroduct.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor
Ask a doctor
before use if your child has heart desease, high blood pressure, thryroid
desease, diabetes a cough with too much phlegm ( mucus)* a persistent or
chronic cough as occurs with asthma or chronic bronchitis
Ask a doctor or pharmacist before use if your child is taking any other nasal descongestant or stimulant, sedatives, tranquilizer, andndrugs used for depression, especially monoamine oxidase inhibitors (MAOIs)* When using this product do not use more than directed
Stop use and ask a Doctor if * nervousness,dizziness or sleeplesness 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 haedache . These could be signs of serious conditions.
OTC - PREGNANCY OR BREAST FEEDING SECTION
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 inmediatly
DOSAGE FORMS & STRENGTHS SECTION
Drug Facts
Active Ingredients (
in each 2.5 ml) Purposes
Dextrometorphan HBr, 7.5 mg ----------------------Cough suppresant
Guafenesin, 150 mg -----------------------------------Expectorant
Phenylepryne HCL, 5 mg -----------------------------Nasal Decongestant
PEDIATRIC USE SECTION
Use section
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 your child get to sleep* helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubestemporary relieves nasal congestion due to a coldstuffy nose
DOSAGE & ADMINISTRATION SECTION
Directions and other information
Directions* no take more than 6 doses in any 24 hours period * use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter
Children under 4 years ----Consult a doctor
children 4 to under 6 years------1.25 ml every 4 hours
children 6 to under 12 years-----2.5 ml every 4 hours
children 12 yeras and over -------5 ml every 4 hours
Other information
store at room temperature 15 - 30 0c* close cap tightly* save carton for
complete drug facts
OTC - QUESTIONS SECTION
Questions section
Call 1-787-848-9114, Monday-Friday 9AM-5PM EST
Call your doctor for medical advice in the event of side efects
OTC - ACTIVE INGREDIENT SECTION
Active ingredients section
Active ingredients ( in each 2.5 ml)
Dextrometorphan HBr, 7.5 mg
Guaifenesin,150 mg
Phenylephryne, 5 mg
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Inactive Ingredients
Citric Acid, Flavor, Glycerin, Hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
Keep out of reach of children.
In case of accidental overdose , get medical or professional help or contact a Poison Control Center inmediatly
OTC - PURPOSE SECTION
Purpose sectiion
Purpose sectiion
Cough Suppressant
Expectorant
Nasal descongestant