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.
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
Dextromethorphan HBr , 15 mg
Guaifenesin, 300 mg
Phenylephryne HCl, 10 mg
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
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 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 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)
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, 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
Store at room temperature , between 15-30 oC
Keep thigtly closed
Save carton for complete drug facts
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 section
In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediatly.
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
maximun strength
Giltuss Cold & cold
Alcohol free
Sugar free
Dye free
Cough, Phlem & Stuffy nose
Non-drowsy
Cherry flavor
4 flox 118 ml
| 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 |
|---|---|---|---|---|---|---|
| 65852-012-04 | Giltuss Cough and Cold | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 65852-012-04 | Giltuss Cough and Cold | 113 mL in 1 BOTTLE, PLASTIC | SOLUTION | 113 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65852-012 | 65852-012-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| HYDROXYETHYLCELLULOSE | T4V6TWG28D | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CITRIC ACID | 2968PHW8QP | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
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 Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f12ee8f-d1c6-d73a-e063-6394a90a9199 | 2025-09-18 | Warnings | 65852-012-04 65852-012 65852001204 3f12ee8f-d1c7-d73a-e063-6394a90a9199 3f12ee8f-d1c6-d73a-e063-6394a90a9199 |
Adverse event summaries are temporarily unavailable. Other product information remains available.