Rompe Pecho
- Manufacturer
- Efficient Laboratories, Inc.
- Effective date
- 2025-10-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 15
- Source
- full-release
- Hydrated at
- 2026-06-01 01:38:53
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (In each 5ml teaspoonful)................. Purpose
Guaifenesin 100 mg ...................................................... Expectorant
OTC - PURPOSE SECTION
Purpose
Expectorant
INDICATIONS & USAGE SECTION
Uses
•
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome
mucus
WARNINGS SECTION
Warnings
Do not exceed recommended dosage.
Ask a doctor before use if you have
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
OTC - DO NOT USE SECTION
Stop use and ask a doctor if
•
cough persists for more than 1 week, tends to recur, or is accompainied by a fever, rash or persistent headache. A persistent cough may be a sign of serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of accidental overdose, get medical help or contact the Poison Control Center right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
Directions:Shake well before use. Do not exceed 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 (2tsps) 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 |
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerin, Golden Seal Root extract, Honey Flavor, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.
OTC - QUESTIONS SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 310604 | guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 15 |
| 1112205 | Rompe Pecho 100 MG in 5 mL Oral Solution | PSN | 15 |
| 1112205 | guaifenesin 20 MG/ML Oral Solution [Rompe Pecho] | SBD | 15 |
| 310604 | guaifenesin 20 MG/ML Oral Solution | SCD | 15 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Solution | SY | 15 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Syrup | SY | 15 |
| 310604 | guaifenesin 200 MG per 10 ML Oral Solution | SY | 15 |
| 310604 | guaifenesin 300 MG per 15 ML Oral Solution | SY | 15 |
| 310604 | guaifenesin 400 MG per 20 ML Oral Solution | SY | 15 |
| 1112205 | Rompe Pecho 100 MG per 5 ML Oral Solution | SY | 15 |
| 1112205 | Rompe Pecho 20 MG/ML Oral Solution | SY | 15 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| 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 | 22-6873 Efficient Labs PDF PROOF SF (done).jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58593-265-04 | Rompe PechoSF | 118 mL in 1 BOTTLE | LIQUID | 118 | 15 | |
| 58593-265-06 | Rompe PechoSF | 178 mL in 1 BOTTLE | LIQUID | 178 | 15 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 4 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 4 | |
| CAULOPHYLLUM THALICTROIDES ROOT | INACTIVE INGREDIENT | JTJ6HH6YEH | 4 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 4 | |
| ECHINACEA, UNSPECIFIED | INACTIVE INGREDIENT | 4N9P6CC1DX | 4 | |
| EUCALYPTUS OIL | INACTIVE INGREDIENT | 2R04ONI662 | 4 | |
| GINKGO | INACTIVE INGREDIENT | 19FUJ2C58T | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 4 | |
| GLYCYRRHIZA GLABRA | INACTIVE INGREDIENT | 2788Z9758H | 4 | |
| GOLDENSEAL | INACTIVE INGREDIENT | ZW3Z11D0JV | 4 | |
| HOREHOUND | INACTIVE INGREDIENT | K08036XEJV | 4 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 4 | |
| MYRRH | INACTIVE INGREDIENT | JC71GJ1F3L | 4 | |
| POTASSIUM CITRATE | INACTIVE INGREDIENT | EE90ONI6FF | 4 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 4 | |
| PRUNUS SEROTINA BARK | INACTIVE INGREDIENT | 5D48E975HA | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 4 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 4 | |
| ULMUS RUBRA BARK | INACTIVE INGREDIENT | 91QY4PXU8Q | 4 | |
| VERBASCUM DENSIFLORUM LEAF | INACTIVE INGREDIENT | 9936O846LI | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 | |
| ZINC SULFATE | INACTIVE INGREDIENT | 89DS0H96TB | 4 |
Products#
Every source-derived product name is available through these pages.
- Rompe Pecho SF
- Guaifenesin
- SUCRALOSE
- CAULOPHYLLUM THALICTROIDES ROOT
- CITRIC ACID MONOHYDRATE
- ECHINACEA, UNSPECIFIED
- EUCALYPTUS OIL
- GINKGO
- GLYCERIN
- GOLDENSEAL
- HOREHOUND
- GLYCYRRHIZA GLABRA
- MENTHOL
- METHYLPARABEN
- VERBASCUM DENSIFLORUM LEAF
- MYRRH
- POTASSIUM CITRATE
- POTASSIUM SORBATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- ULMUS RUBRA BARK
- SODIUM CHLORIDE
- ZINC SULFATE
- PRUNUS SEROTINA BARK
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58593-265 | 58593-265-04, 58593-265-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 14 | 2024-10-14 | full-release | 2026-06-01 00:25:15 |
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 |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ORAL | 98 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GRANULE, FOR SUSPENSION / ORAL | 162 mg | ||
| POTASSIUM CITRATE | POTASSIUM CITRATE | EE90ONI6FF | POWDER, FOR SOLUTION / ORAL | 570 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, COATED / ORAL | 54.7 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CAPSULE / ORAL | 0.87 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET, ORALLY DISINTEGRATING / ORAL | 14 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION, CONCENTRATE / ORAL | 0.5 mg/1ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / ORAL | 148 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, FILM COATED / ORAL | 100 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SYRUP / ORAL | 2 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, CHEWABLE / ORAL | 20 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CAPSULE / ORAL | NA | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION / ORAL | 383 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CONCENTRATE / ORAL | 1 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SOLUTION / ORAL | 1000 mg/15ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | ELIXIR / ORAL | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / NASAL | 7.4 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE, EXTENDED RELEASE / ORAL | 41 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SYRUP / ORAL | 7.5 mg/5ml | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / NASAL | 7.4 mg/1ml | ||
| POTASSIUM CITRATE | POTASSIUM CITRATE | EE90ONI6FF | SOLUTION / ORAL | 913 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ORAL | 98 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CAPSULE / ORAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET / ORAL | 231 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, DELAYED RELEASE / ORAL | 97 mg | ||
| POTASSIUM CITRATE | POTASSIUM CITRATE | EE90ONI6FF | SUSPENSION / ORAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SUSPENSION / ORAL | 400 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET / ORAL | 0.58 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | ELIXIR / ORAL | 1 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION / ORAL | 3 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| ZINC SULFATE | ZINC SULFATE | 89DS0H96TB | DOUCHE / VAGINAL | 5 %w/w | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GRANULE, FOR SUSPENSION / ORAL | 162 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | POWDER, FOR SOLUTION / ORAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ORAL | 98 mg | ||
| POTASSIUM CITRATE | POTASSIUM CITRATE | EE90ONI6FF | POWDER, FOR SOLUTION / ORAL | 570 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / ORAL | NA | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CONCENTRATE / ORAL | 0.05 mg/5ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET / ORAL | 6 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SYRUP / ORAL | 80 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, DELAYED RELEASE / ORAL | 97 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE / ORAL | 6 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE, EXTENDED RELEASE / ORAL | 41 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 SF | GUAIFENESIN | Efficient Laboratories, Inc. | 31ff48fc-9603-413c-ab7c-2598b3e08f9c | 2025-10-14 | Warnings | 58593-265-04 58593-265-06 58593-265 58593026506 58593026504 411e96f1-d9a3-1820-e063-6294a90a8a69 31ff48fc-9603-413c-ab7c-2598b3e08f9c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
