Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 5 mL) Dextromethorphan HBr, 10 mg Guaifenesin, 100 mg
OTC - PURPOSE SECTION
Purposes Cough Suppressant Expectorant
Childrens 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
Key Label Information#
Uses
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
WARNINGS SECTION
Warnings
Directions And Dosage
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 children under 4 years Consult a doctor children 4 to under 6 years 2.5 mL every 4 hours children 6 to under 12 years 5 mL every 4 hours children 12 years and over 10 mL every 4 hours
Other Label Information
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 ingredients carboxymethycellulose 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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Children 4-12 Children's Giltuss® Honey Cough & Chest Congestion Made with real honey Alcohol Free, Dye Free, Non Drowsy COUGH AND COLD CHEST CONGESTION LIQUIFIES AND LOOSENS PHLEGM AND MUCUS HONEY LEMON FLAVOR 4FL OZ (118 mL)
Label Images#
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 |
|---|---|---|---|---|---|
| 58552-141-04 | 2022-01-30 | C162847 | 48780-1 | d6a99b39-75cb-a426-e053-dadaa90af4c2 | Childrens Giltuss Honey Cough & Chest Congestion |
| 58552-141-04 | 2022-01-30 | C162847 | 48780-1 | d6a99b39-75cb-a426-e053-dadaa90af4c2 | Childrens Giltuss Honey Cough & Chest Congestion |
| 58552-141-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-75cb-a426-e053-dadaa90af4c2 | Childrens Giltuss Honey Cough & Chest Congestion |
| 58552-141-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-75cb-a426-e053-dadaa90af4c2 | Childrens Giltuss Honey Cough & Chest Congestion |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58552-141-04 | Childrens Giltuss Honey Cough and Chest Congestion | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 58552-141-04 | Childrens 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 |
|---|---|---|---|---|---|
| 58552-141-04 | ML - Milliliter | 58552-141 | 6a507480-ad16-43bb-a524-2be238c45529 | 1 | 2021-01-08 |
Products#
- Childrens Giltuss Honey Cough and Chest Congestion
- Dextromethorphan HBr, Guaifenesin
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58552-141 | 58552-141-04 |
Ingredients#
| 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 |
Complete SPL Sections#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 5 mL) Dextromethorphan HBr, 10 mg Guaifenesin, 100 mg
OTC - PURPOSE SECTION
Purposes Cough Suppressant 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
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 children under 4 years Consult a doctor children 4 to under 6 years 2.5 mL every 4 hours children 6 to under 12 years 5 mL every 4 hours children 12 years and over 10 mL every 4 hours
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 ingredients carboxymethycellulose 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
Children 4-12 Children's Giltuss® Honey Cough & Chest Congestion Made with real honey Alcohol Free, Dye Free, Non Drowsy COUGH AND COLD CHEST CONGESTION LIQUIFIES AND LOOSENS PHLEGM AND MUCUS HONEY LEMON FLAVOR 4FL OZ (118 mL)
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2024-10-24 | full-release | 2026-06-01 00:29:57 |