Indications and uses
Uses: temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Rompe Pechito
- Manufacturer
- Efficient Laboratories Inc
- Effective date
- 2025-10-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:38:52
Label at a glance#
ProductRompe Pechito DM for Kids
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 sections
Dosage and administration
Do not give more than 6 doses in any 24 hours period shake well before use measure only with dosing cup provided keep dosing cup with product mL = milliliter Age Dose 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 Do not use
Contacts and useful links#
Websitewww.efficientlabs.com
www.efficientlabs.com
www.efficientlabs.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:(in each teaspoonful 2.5 ml.) Purpose
Dextromethorphan Hydrobromide 5 mg ...................................... Cough Suppressant
Guaifenesin 50 mg ................................................................... Expectorant
OTC - PURPOSE SECTION
Purpose
Cough Suppressant
Expectorant
Uses
Uses:
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Warnings
Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Do not use
Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Do not give more than 6 doses in any 24 hours period shake well before use measure only with dosing cup provided keep dosing cup with product mL = milliliter
Age Dose
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 Do not use
Inactive Ingredients:
Inactive Ingredients: citric acid, elderberry fruit extract, glycerin, honey, maltodextrin, methylparaben, flavor, potassium sorbate as a preservative, propylparaben, propylene glycol, purified water, sodium chloride, sucralose and zinc sulfate.
OTC - QUESTIONS SECTION
Stop use and ask a doctor if
cough that occurs with too much phlegm (mucus)
persistent or chronic cough, such as occurs with asthma or chronic bronchitis.
These could be signs of a serious condition.
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough, such as occurs with asthma or chronic bronchitis
Other Information
- store this product between 15 to 30 °C (59 to 86 °F )
- do not refrigerate
- product color & flavor may vary due to natural honey
Tamper-Evident Feature: do not use this product if printed security seal is torn, broken or missing.
Rompe Pechito
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 5 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 5 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 5 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 5 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 5 |
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 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code | www.efficientlabs.com/ | ROMPE PECHITO BOX DIE 4 OZ JULIO-_Page_1.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58593-276-04 | Rompe PechitoDM for Kids | 118 mL in 1 BOTTLE | LIQUID | 118 | 5 |
Products#
Every source-derived product name is available through these pages.
- Rompe Pechito DM for Kids
- Dextromethorphan HBr, Guaifenesin
- SUCRALOSE
- ANHYDROUS CITRIC ACID
- AMERICAN ELDERBERRY
- MALTODEXTRIN
- METHYLPARABEN
- HONEY
- POTASSIUM SORBATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CHLORIDE
- ZINC SULFATE
- GLYCERIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58593-276 | 58593-276-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| AMERICAN ELDERBERRY | 7610Y219OC | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| HONEY | Y9H1V576FH | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| ZINC SULFATE | 89DS0H96TB | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2024-11-07 | full-release | 2026-06-01 00:35:16 |
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 |
|---|---|---|---|---|---|---|
| Rompe Pechito DM for Kids | DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | 004d12e1-6e3d-84c8-e063-6394a90aa653 | 2025-10-14 | Warnings | 58593-276-04 58593-276 58593027604 411e99da-2482-40c7-e063-6394a90aaf80 004d12e1-6e3d-84c8-e063-6394a90aa653 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.