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Giltuss Childrens Cough and Cold

Children's Giltuss Cough & Cold

Approved
Approval ID

3f025ef6-79e7-e833-e063-6294a90ab501

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

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
NDC Product Code65852-011
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (13)

DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 7.5 mg in 2.5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 2.5 mL
Code: 04JA59TNSJ
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GUAIFENESINActive
Quantity: 150 mg in 2.5 mL
Code: 495W7451VQ
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/7/2018

Principal panel

Childrens 4-12

Cough & Cold

Alcohol free

Sugar free

Dye free

Non -Drowsy

Cherry Flavor Principal panel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/7/2018

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

indication an user

WARNINGS SECTION

LOINC: 34071-1Updated: 11/7/2018

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.warnings

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 11/7/2018

Ask a doctor

Ask a doctorAsk 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

LOINC: 53414-9Updated: 11/7/2018

If pregnantIf 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

LOINC: 43678-2Updated: 11/7/2018

Drug Facts

drugActive 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

LOINC: 34081-0Updated: 11/7/2018

Use section

usesUses * 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

LOINC: 34068-7Updated: 11/7/2018

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 Directions

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/7/2018

Questions section

Call 1-787-848-9114, Monday-Friday 9AM-5PM EST

Call your doctor for medical advice in the event of side efects Questions

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/7/2018

Active ingredients section

Active ingredients ( in each 2.5 ml)

Dextrometorphan HBr, 7.5 mg

Guaifenesin,150 mg

Phenylephryne, 5 mg Active ingredients

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/7/2018

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

LOINC: 50565-1Updated: 11/7/2018

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

Keep out

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/7/2018

Purpose sectiion

Purpose sectiion

Cough Suppressant

Expectorant

Nasal descongestant

purpose

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Giltuss Childrens Cough and Cold - FDA Drug Approval Details