Storage and handling
Other information store at room temperature 15°-30°C (59°-86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS
Childrens Giltuss Honey DM Cough
- 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#
ProductChildrens Giltuss Honey DM Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 5 mL)
Dextromethorphan HBr, 15 mg
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
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not useif your child is 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 child prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- a persistent or chronic cough such as occurs with asthma
OTC - STOP USE SECTION
Stop use and ask a doctor if the child hasa cough that 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 - 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 4 doses in any 24-hour period
- use enclosed dosing 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 6-8 hours |
| children 6 to under 12 years | 5 mL every 6-8 hours |
| children 12 years and over | 10 mL every 6-8 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 ingredientsnatural and artificial flavor, natural grade A honey, methylparaben, potassium sorbate, 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 DM Cough
Alcohol Free. Dye Free. Non Drowsy.
PERSISTENT COUGH UP TO 8 HOURS
Made with real honey
HONEY LEMON FLAVOR.
4FL OZ (118 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1090496 | dextromethorphan HBr 15 MG in 5 mL Oral Solution | PSN | 6 |
| 1090496 | dextromethorphan hydrobromide 3 MG/ML Oral Solution | SCD | 6 |
| 1090496 | dextromethorphan hydrobromide 15 MG per 5 ML Oral Solution | SY | 6 |
| 1090496 | dextromethorphan hydrobromide 30 MG per 10 ML Oral Solution | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58552-144-04 | 2022-01-30 | C162847 | 48780-1 | d6a99b39-dd33-a426-e053-dadaa90af4c2 | Giltuss Honey DM, Childrens |
| 58552-144-04 | 2022-01-30 | C162847 | 48780-1 | d6a99b39-dd33-a426-e053-dadaa90af4c2 | Giltuss Honey DM, Childrens |
| 58552-144-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-dd33-a426-e053-dadaa90af4c2 | Giltuss Honey DM, Childrens |
| 58552-144-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-dd33-a426-e053-dadaa90af4c2 | Giltuss Honey DM, Childrens |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58552-144-04 | Childrens Giltuss Honey DM Cough | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 58552-144-04 | Childrens Giltuss Honey DM Cough | 118 mL in 1 BOTTLE | SOLUTION | 118 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58552-144-04 | ML - Milliliter | 58552-144 | ab3ef6c4-661a-4458-8904-6e3c913b5ab5 | 1 | 2022-07-06 |
Products#
Every source-derived product name is available through these pages.
- Childrens Giltuss Honey DM Cough
- Dextromethorphan HBr
- POTASSIUM SORBATE
- WATER
- PROPYLENE GLYCOL
- SUCRALOSE
- HONEY
- METHYLPARABEN
- PROPYLPARABEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58552-144 | 58552-144-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| WATER | 059QF0KO0R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| HONEY | Y9H1V576FH | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2024-10-24 | full-release | 2026-06-01 00:29:57 |
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 |
|---|---|---|---|---|---|---|
| Childrens Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Gil Pharmaceutical Corp | a8c5027f-9701-fb07-e053-2a95a90a6029 | 2025-10-09 | Warnings | 58552-144-04 58552-144 58552014404 40b8c1dc-4837-be7b-e063-6394a90a26f8 a8c5027f-9701-fb07-e053-2a95a90a6029 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.