Rompe Pecho Max Multi Symptoms
- Manufacturer
- EFFICIENT LABORATORIES INC
- Effective date
- 2024-11-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-06-01 00:35:42
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients Purposes
(in each 20mL)
Acetaminophen 650 mg..................................Pain reliever/feverreducer
Dextromethorphan Hbr 20 mg............................Cough suppressant
Guaifenesin 400 mg...........................................Expectorant
Phenylephtine HCl 10 mg...................................Nasal decongestant
OTC - PURPOSE SECTION
- Pain reliever/fever reducer
- Cough suppressant
- Expectorant
- Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
- temprarily relieves these common cold and flu symptoms:
- nasal congestion
- sinus congestion and pressure
- cough due to minor throat and bronchial irritation
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
- promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
WARNINGS SECTION
Warning
Liver warning: this product contains acetaminophen.
Severe liver damage may occur if:
- you take more than 6 doses in 24 hours, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- 3 or more alcoholic drinkss every day while using this product.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash.
If skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by, fever, headahce, rash, nausea or vomiting, consult a doctor promtly.
OTC - DO NOT USE SECTION
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription).
- if you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
- if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
- 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 a doctor or pharmamcist before taking this product.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor before use if you have
- heart disease
- liver disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to an enlarged prostate gland
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- a cough that is followed by excessive phlegm (mucus)
Ask a docotor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking tranquilizers or sedatives
OTC - WHEN USING SECTION
When using this product do not use more than directed
OTC - STOP USE SECTION
Stop use and ask a doctor if
- symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition
- nervousness, dizziness or sleeplessness occurs
- pain and nasal congestion gets worse or last more than 5 days (children) or 7 days (adults)
- fever gets worse or last more than 3 days
- redness or swelling is present or new symptoms occur.
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.
OVERDOSAGE SECTION
Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than 6 doses in any 24 hours
- shake well before use
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
- this adult strength product is not intended for use in children under 12 years of age
| age | dose |
| adults and children 12 years of age and over | 20 mL every 4 hours |
| children under 12 years of age | do not use |
INACTIVE INGREDIENT SECTION
Inactive ingreadients:
Blue cohosh root extract, citirc acid, echinacea root extract, eucalptus oil, ginko biloba leaf extract, glycerin, goldenseal root extract, honey, horehound (flower, leaf, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum, potassium citrate, potassium sorbate, propylene glycol, propylparaben, slippery elm bark extract, sodium chloride, suralose, water, wild cherry bark extract and zinc sulfate.
OTC - QUESTIONS SECTION
Questions or comments?
(305) 805-3456 Monday to Friday from 9 am to 5 pm EST or
www.efficientlabs.com
RECENT MAJOR CHANGES SECTION
Recommendations should be added in the Directions section, such as:
• do not take more 6 doses in any 24 hours
• measure only with dosing cup provided
• keep dosing cup with product
• mL= milliliter
• this strength product is not intended for use in children under 12 years of age
Typographical adjustments were made, and clarity was provided on the dosage by age through a table:
| age | dose |
| adults and children 12 years of age and over | 20 mL every 4 hours |
| children under 12 years of age | do not use |
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1593450 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Suspension | PSN | 10 |
| 1593450 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Suspension | SCD | 10 |
| 1593450 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Suspension | SY | 10 |
| 1593450 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Suspension | SY | 10 |
| 1593450 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Suspension | SY | 10 |
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 |
|---|---|---|---|---|---|
| 58593-828-08 | 2023-08-03 | C162847 | 48780-1 | 9d75b9cf-dbc8-f424-e053-dadaa90a57ce | 938e4e47-d2d9-4b0d-bf88-e9f41b501945 |
| 58593-828-08 | 2023-07-28 | C162847 | 48780-1 | 9d75b9cf-dbc8-f424-e053-dadaa90a57ce | 938e4e47-d2d9-4b0d-bf88-e9f41b501945 |
| 58593-828-08 | 2020-02-16 | C162847 | 48780-1 | 9d75b9cf-dbc8-f424-e053-dadaa90a57ce | 938e4e47-d2d9-4b0d-bf88-e9f41b501945 |
| 58593-828-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dbc8-f424-e053-dadaa90a57ce | 938e4e47-d2d9-4b0d-bf88-e9f41b501945 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58593-828-08 | Rompe Pecho Max Multi Symptoms | 1 in 1 CARTON | LIQUID | 1 | 10 | |
| 58593-828-08 | Rompe Pecho Max Multi Symptoms | 237 mL in 1 BOTTLE | LIQUID | 237 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58593-828 | ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241109_938e4e47-d2d9-4b0d-bf88-e9f41b501945.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| CAULOPHYLLUM THALICTROIDES ROOT | INACTIVE INGREDIENT | JTJ6HH6YEH | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| ECHINACEA, UNSPECIFIED | INACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| EUCALYPTUS OIL | INACTIVE INGREDIENT | 2R04ONI662 | 1 | |
| GINKGO | INACTIVE INGREDIENT | 19FUJ2C58T | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GOLDENSEAL | INACTIVE INGREDIENT | ZW3Z11D0JV | 1 | |
| HONEY | INACTIVE INGREDIENT | Y9H1V576FH | 1 | |
| HOREHOUND | INACTIVE INGREDIENT | K08036XEJV | 1 | |
| LICORICE | INACTIVE INGREDIENT | 61ZBX54883 | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MULLEIN LEAF | INACTIVE INGREDIENT | 9936O846LI | 1 | |
| MYRRH | INACTIVE INGREDIENT | JC71GJ1F3L | 1 | |
| POTASSIUM CITRATE | INACTIVE INGREDIENT | EE90ONI6FF | 1 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| PRUNUS SEROTINA BARK | INACTIVE INGREDIENT | 5D48E975HA | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| ULMUS RUBRA BARK | INACTIVE INGREDIENT | 91QY4PXU8Q | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| ZINC SULFATE | INACTIVE INGREDIENT | 89DS0H96TB | 1 |
Products#
Every source-derived product name is available through these pages.
- Rompe Pecho Max Multi Symptoms
- Acetaminophen, Dextromethophan HBr, Phenylephrine HCl, Guaifenesin
- WATER
- PRUNUS SEROTINA BARK
- ZINC SULFATE
- CAULOPHYLLUM THALICTROIDES ROOT
- CITRIC ACID MONOHYDRATE
- ECHINACEA, UNSPECIFIED
- EUCALYPTUS OIL
- GINKGO
- GLYCERIN
- GOLDENSEAL
- HONEY
- HOREHOUND
- LICORICE
- MENTHOL
- METHYLPARABEN
- MULLEIN LEAF
- MYRRH
- POTASSIUM CITRATE
- POTASSIUM SORBATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- ULMUS RUBRA BARK
- SODIUM CHLORIDE
- SUCRALOSE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58593-828 | 58593-828-08 |
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 |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE / ORAL | 6 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYRUP / ORAL | 40 mg | ||
| POTASSIUM CITRATE | POTASSIUM CITRATE | EE90ONI6FF | SUSPENSION / ORAL | NA | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET / ORAL | 6 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET / ORAL | 6 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET / ORAL | 231 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SYRUP / ORAL | 2 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| EUCALYPTUS OIL | EUCALYPTUS OIL | 2R04ONI662 | SYRUP / ORAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| POTASSIUM CITRATE | POTASSIUM CITRATE | EE90ONI6FF | SUSPENSION / ORAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / SUBCUTANEOUS | 0.7 %w/v | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SYRUP / ORAL | 7.5 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SYRUP / ORAL | 80 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | POWDER, FOR SOLUTION / ORAL | NA | ||
| ZINC SULFATE | ZINC SULFATE | 89DS0H96TB | DOUCHE / VAGINAL | 5 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / SUBCUTANEOUS | 0.7 %w/v | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SUSPENSION / ORAL | 400 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / ORAL | 148 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | PASTE / ORAL | 48 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET / ORAL | 0.58 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / ORAL | 2 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | ELIXIR / ORAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / ORAL | 2 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SUSPENSION / ORAL | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| EUCALYPTUS OIL | EUCALYPTUS OIL | 2R04ONI662 | SYRUP / ORAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, FILM COATED / ORAL | 100 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET / ORAL | 231 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SOLUTION / ORAL | 414 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| POTASSIUM CITRATE | POTASSIUM CITRATE | EE90ONI6FF | SOLUTION / ORAL | 913 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | PASTE / ORAL | 48 mg | ||
| POTASSIUM CITRATE | POTASSIUM CITRATE | EE90ONI6FF | SOLUTION / ORAL | 913 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ORAL | 98 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / ORAL | NA | ||
| POTASSIUM CITRATE | POTASSIUM CITRATE | EE90ONI6FF | POWDER, FOR SOLUTION / ORAL | 570 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM, SOLUBLE / ORAL | 33 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ORAL | 98 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION, EXTENDED RELEASE / ORAL | 16 mg | ||
| ZINC SULFATE | ZINC SULFATE | 89DS0H96TB | DOUCHE / VAGINAL | 5 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, EXTENDED RELEASE / ORAL | 335.1 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | POWDER, FOR SOLUTION / ORAL | NA |
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 Max Multi Symptoms | ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN | EFFICIENT LABORATORIES INC | 938e4e47-d2d9-4b0d-bf88-e9f41b501945 | 2024-11-07 | Warnings | 58593-828-08 58593-828 58593082808 265921fa-a795-0300-e063-6294a90a6793 938e4e47-d2d9-4b0d-bf88-e9f41b501945 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

