Storage and handling
Other information store at room temperature 15°-30°C (59°-86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS
Giltuss Honey Cough and Chest Congestion
- Manufacturer
- Gil Pharmaceutical Corp | Dextrum Laboratories Inc
- Effective date
- 2025-10-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 01:38:36
Label at a glance#
ProductGiltuss Honey Cough and Chest Congestion
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure11 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 10 mL)
Dextromethorphan HBr, 20 mg
Guaifenesin, 200 mg
OTC - PURPOSE SECTION
Purposes
Cough Suppresant
Expectorant
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves:
- cough due to minor throat and bronchial irritation associated 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 coughs more productive and drain bronchial tubes
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not useif 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
OTC - ASK DOCTOR SECTION
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
OTC - STOP USE SECTION
Stop use and ask a doctor ifcough lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than 6 doses in any 24-hour period
- use enclosed dosinc cup
- keep dosage cup for use with this product
- ml = milliliters
adults and children 12 years and 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
STORAGE AND HANDLING SECTION
Other information
- store at room temperature 15°-30°C (59°-86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
INACTIVE INGREDIENT SECTION
Inactive ingredientscarboxymethycellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water, sucralose.
OTC - QUESTIONS SECTION
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.
SPL UNCLASSIFIED SECTION
Tamper Evident: do not use if safety seal is broken or missing.
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MAXIMUM STRENGTH
Giltuss®
Honey Cough & Chest Congestion
Made with real honey
ALCOHOL FREE. DYE FREE. NON-DROWSY
RELIEVES
COUGH AND COLD
CHEST CONGESTION
LIQUIFIES AND LOOSENS PHLEGM AND MUCUS
HONEY LEMON FLAVOR
4FL OZ (118 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 6 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 6 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 6 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 6 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58552-140-04 | 2022-01-30 | C162847 | 48780-1 | d6a99b39-dcea-a426-e053-dadaa90af4c2 | Giltuss Honey Cough & Chest Congestion |
| 58552-140-04 | 2022-01-30 | C162847 | 48780-1 | d6a99b39-dcea-a426-e053-dadaa90af4c2 | Giltuss Honey Cough & Chest Congestion |
| 58552-140-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-dcea-a426-e053-dadaa90af4c2 | Giltuss Honey Cough & Chest Congestion |
| 58552-140-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-dcea-a426-e053-dadaa90af4c2 | Giltuss Honey Cough & Chest Congestion |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58552-140-04 | Giltuss Honey Cough and Chest Congestion | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 58552-140-04 | Giltuss Honey Cough and Chest Congestion | 118 mL in 1 BOTTLE | SOLUTION | 118 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58552-140-04 | ML - Milliliter | 58552-140 | 457e8127-e5cd-40ec-b243-3b9ce63c901c | 1 | 2021-01-08 |
Products#
Every source-derived product name is available through these pages.
- Giltuss Honey Cough and Chest Congestion
- Dextromethorphan HBr, Guaifenesin
- CARBOXYMETHYLCELLULOSE SODIUM
- WATER
- GLYCERIN
- PROPYLENE GLYCOL
- SUCRALOSE
- ANHYDROUS CITRIC ACID
- HONEY
- METHYLPARABEN
- PROPYLPARABEN
- GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58552-140 | 58552-140-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| HONEY | Y9H1V576FH | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2024-10-24 | full-release | 2026-06-01 00:29:56 |
openFDA label cross-check#
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 Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Gil Pharmaceutical Corp | a8b2c847-25e9-8714-e053-2995a90a73ce | 2025-10-09 | Warnings | 58552-140-04 58552-140 58552014004 40b8aa4b-9a4a-7312-e063-6394a90a7952 a8b2c847-25e9-8714-e053-2995a90a73ce |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.