Rompe Pecho
- Manufacturer
- Efficient Laboratories Inc
- Effective date
- 2025-09-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 26
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:16
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:(in each teaspoonful 5 ml.) Purpose
Dextromethorphan HBr 10 mg ...................................... Cough Suppressant
Guaifenesin 100 mg ................................................................... Expectorant
Phenylephrine HCL 5 mg .................................................... Nasal Decongestant
OTC - PURPOSE SECTION
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
WARNINGS SECTION
Warnings
Do not exceed recommended dosage.
Do not use
- If you are 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 your doctor or pharmacist before taking this product.
OTC - DO NOT USE SECTION
Ask a doctor before use if you have
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• a persistant or chronic cough
- a cough that is accompanied by excessive phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Stop use and ask doctor if
- symptoms do not improve within 7 days or is accompanied by a fever, rash, or persistent headache. A persistent cough may be sign of a serious condition.
- nervousness, dizziness, or sleeplessness occurs
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 accidental overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
Shake well before use
Do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.
| Age | Dose |
adults and children 12 years of age and over | 10 mL (2 tsps) every 4 hours |
| children 6 to under 12 years of age | 5 mL (1 tsp) every 4 hours |
| children under 6 years of age | consult a doctor |
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves cough and nasal congestion as may occur with the common cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.
INACTIVE INGREDIENT SECTION
Inactive Ingredients:Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.
OTC - QUESTIONS SECTION
Questions or Comments?
305-805-3456 Monday - Friday 9AM to 5PM EST
Distributed by
Efficient Laboratories, Inc., Miami, Fl 33166
Made in U.S.A.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1044949 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution | PSN | 26 |
| 1044949 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | 26 |
| 1044949 | dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution | SY | 26 |
| 1044949 | dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution | SY | 26 |
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 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58593-235-04 | 2023-08-03 | C162847 | 48780-1 | 0191ceaa-62aa-198a-e063-dbdaa90aec3e | Drug Facts |
| 58593-235-06 | 2023-08-03 | C162847 | 48780-1 | 0191ceaa-62aa-198a-e063-dbdaa90aec3e | Drug Facts |
| 58593-235-08 | 2023-08-03 | C162847 | 48780-1 | 0191ceaa-62aa-198a-e063-dbdaa90aec3e | Drug Facts |
| 58593-235-10 | 2023-08-03 | C162847 | 48780-1 | 0191ceaa-62aa-198a-e063-dbdaa90aec3e | Drug Facts |
| 58593-235-29 | 2023-08-03 | C162847 | 48780-1 | 0191ceaa-62aa-198a-e063-dbdaa90aec3e | Drug Facts |
| 58593-235-04 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-62aa-198a-e063-dbdaa90aec3e | Drug Facts |
| 58593-235-06 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-62aa-198a-e063-dbdaa90aec3e | Drug Facts |
| 58593-235-08 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-62aa-198a-e063-dbdaa90aec3e | Drug Facts |
| 58593-235-10 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-62aa-198a-e063-dbdaa90aec3e | Drug Facts |
| 58593-235-29 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-62aa-198a-e063-dbdaa90aec3e | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58593-235-04 | Rompe PechoCF | 118 mL in 1 BOTTLE | LIQUID | 118 | 26 | |
| 58593-235-06 | Rompe PechoCF | 178 mL in 1 BOTTLE | LIQUID | 178 | 26 | |
| 58593-235-08 | Rompe PechoCF | 237 mL in 1 BOTTLE | LIQUID | 237 | 26 | |
| 58593-235-10 | Rompe PechoCF | 10 mL in 1 POUCH | LIQUID | 10 | 26 | |
| 58593-235-29 | Rompe PechoCF | 296 mL in 1 BOTTLE | LIQUID | 296 | 26 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 5 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 5 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 5 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 5 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 5 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 5 | |
| CAULOPHYLLUM THALICTROIDES ROOT | INACTIVE INGREDIENT | JTJ6HH6YEH | 5 | |
| ECHINACEA, UNSPECIFIED | INACTIVE INGREDIENT | 4N9P6CC1DX | 5 | |
| EUCALYPTUS GLOBULUS LEAF | INACTIVE INGREDIENT | S546YLW6E6 | 5 | |
| GINKGO | INACTIVE INGREDIENT | 19FUJ2C58T | 5 | |
| GLYCYRRHIZA GLABRA | INACTIVE INGREDIENT | 2788Z9758H | 5 | |
| GOLDENSEAL | INACTIVE INGREDIENT | ZW3Z11D0JV | 5 | |
| HONEY | INACTIVE INGREDIENT | Y9H1V576FH | 5 | |
| HOREHOUND | INACTIVE INGREDIENT | K08036XEJV | 5 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 5 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 5 | |
| MYRRH | INACTIVE INGREDIENT | JC71GJ1F3L | 5 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 5 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 5 | |
| PRUNUS SEROTINA BARK | INACTIVE INGREDIENT | 5D48E975HA | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 5 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 5 | |
| ULMUS RUBRA BARK | INACTIVE INGREDIENT | 91QY4PXU8Q | 5 | |
| VERBASCUM DENSIFLORUM LEAF | INACTIVE INGREDIENT | 9936O846LI | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 | |
| ZINC SULFATE | INACTIVE INGREDIENT | 89DS0H96TB | 5 |
Products#
Every source-derived product name is available through these pages.
- Rompe Pecho CF
- Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
- HOREHOUND
- SUCRALOSE
- CAULOPHYLLUM THALICTROIDES ROOT
- ECHINACEA, UNSPECIFIED
- EUCALYPTUS GLOBULUS LEAF
- GINKGO
- GOLDENSEAL
- HONEY
- GLYCYRRHIZA GLABRA
- MENTHOL
- METHYLPARABEN
- VERBASCUM DENSIFLORUM LEAF
- MYRRH
- POTASSIUM SORBATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- ULMUS RUBRA BARK
- SODIUM CHLORIDE
- PRUNUS SEROTINA BARK
- ZINC SULFATE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58593-235 | 58593-235-06, 58593-235-04, 58593-235-08, 58593-235-29, 58593-235-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET, ORALLY DISINTEGRATING / ORAL | 14 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION, CONCENTRATE / ORAL | 0.5 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE / ORAL | 6 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | ELIXIR / ORAL | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GRANULE, FOR SUSPENSION / ORAL | 162 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYRUP / ORAL | 40 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, FILM COATED / ORAL | 100 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION / ORAL | 383 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SOLUTION / ORAL | 414 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAVENOUS | 6320 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CAPSULE / ORAL | 0.87 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SUSPENSION / ORAL | 1 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CONCENTRATE / ORAL | 0.05 mg/5ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET / ORAL | 231 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE, EXTENDED RELEASE / ORAL | 41 mg | ||
| ZINC SULFATE | ZINC SULFATE | 89DS0H96TB | DOUCHE / VAGINAL | 5 %w/w | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAMUSCULAR | 17 mg | ||
| ZINC SULFATE | ZINC SULFATE | 89DS0H96TB | DOUCHE / VAGINAL | 5 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET / ORAL | 0.58 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET / ORAL | 6 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SYRUP / ORAL | 7.5 mg/5ml | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SYRUP / ORAL | 2 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ORAL | 98 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | POWDER, FOR SOLUTION / ORAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM, SOLUBLE / ORAL | 33 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION / ORAL | 3 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CONCENTRATE / ORAL | 1 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION, EXTENDED RELEASE / ORAL | 16 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION / ORAL | 383 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, CHEWABLE / ORAL | 20 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CONCENTRATE / ORAL | 0.05 mg/5ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, FILM COATED / ORAL | 100 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, COATED / ORAL | 54.7 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | POWDER, FOR SOLUTION / ORAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM, SOLUBLE / ORAL | 33 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, COATED / ORAL | 54.7 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SYRUP / ORAL | 7.5 mg/5ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SYRUP / ORAL | 80 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION / ORAL | 3 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYRUP / ORAL | 40 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, EXTENDED RELEASE / ORAL | 335.1 mg |
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 Pecho CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Efficient Laboratories Inc | 96c4dee1-6e66-4442-a7e3-56e874414c17 | 2025-09-09 | Warnings | 58593-235-10 58593-235-08 58593-235-06 58593-235-04 58593-235-29 58593-235 58593023506 58593023529 58593023508 58593023510 58593023504 3e6375e6-6668-3453-e063-6394a90add02 96c4dee1-6e66-4442-a7e3-56e874414c17 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
