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.
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
Active ingredients
Dextromethorpan HBr, 20 mg
Guafenesin , 200 mg
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
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 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
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, 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
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
I
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
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.
In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediatly
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
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 2 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 2 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 2 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 2 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65852-009-04 | Giltuss Diabetic | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 65852-009-04 | Giltuss Diabetic | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65852-009 | 65852-009-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| DEXTROMETHORPHAN HYDROCHLORIDE | 351KFH969D | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CITRIC ACID | 2968PHW8QP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-09-22 | full-release | 2026-06-01 01:15:16 |
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 Diabetic | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories, Inc | 3f64c81a-bbfc-4575-e063-6294a90a6ed7 | 2025-10-06 | Warnings | 65852-009-04 65852-009 65852000904 40806093-e562-0be7-e063-6294a90a949c 3f64c81a-bbfc-4575-e063-6294a90a6ed7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.