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 ...
Dextrometorphan HBr, 7.5 mg ----------------------Cough suppresant
Guafenesin, 150 mg -----------------------------------Expectorant
Phenylepryne HCL, 5 mg -----------------------------Nasal Decongestant
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 tubes*temporary relieves nasal congestion due to a cold*stuffy nose
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.
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.
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
Call 1-787-848-9114, Monday-Friday 9AM-5PM EST
Call your doctor for medical advice in the event of side efects
Active ingredients ( in each 2.5 ml)
Dextrometorphan HBr, 7.5 mg
Guaifenesin,150 mg
Phenylephryne, 5 mg
Inactive Ingredients
Citric Acid, Flavor, Glycerin, Hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose
Keep out of reach of children.
In case of accidental overdose , get medical or professional help or contact a Poison Control Center inmediatly
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
Purpose sectiion
Cough Suppressant
Expectorant
Nasal descongestant
Childrens 4-12
Cough & Cold
Alcohol free
Sugar free
Dye free
Non -Drowsy
Cherry Flavor
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1251031 | dextromethorphan HBr 15 MG / guaiFENesin 300 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution | PSN | 1 |
| 1251031 | dextromethorphan hydrobromide 3 MG/ML / guaifenesin 60 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution | SCD | 1 |
| 1251031 | dextromethorphan HBr 15 MG / guaifenesin 300 MG / phenylephrine HCl 10 MG per 5 ML Oral Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65852-011-04 | Giltuss Childrens Cough and Cold | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 1 | |
| 65852-011-04 | Giltuss Childrens Cough and Cold | 1 in 1 CARTON | SOLUTION | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65852-011 | 65852-011-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| HYDROXYETHYL CELLULOSE, UNSPECIFIED | T4V6TWG28D | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Giltuss Childrens Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f025ef6-79e7-e833-e063-6294a90ab501 | 2025-09-17 | Warnings | 65852-011-04 65852-011 65852001104 3f025ef6-79e8-e833-e063-6294a90ab501 3f025ef6-79e7-e833-e063-6294a90ab501 |
Adverse event summaries are temporarily unavailable. Other product information remains available.