Rompe Pecho NT
- Manufacturer
- Efficient Laboratories Inc
- Effective date
- 2024-10-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 00:23:10
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:(in each 30ml doses cup) Purpose
Acetaminophen 650mg ............................................................ Pain reliever/fever reducer
Dextromethorphan HBr 20 mg ..................................................Cough Suppressant
Doxylamine succinate 12.5 mg ................................................ Antihistamine
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Cough Suppressant
Antihistamine
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur f you take • more than 6 doses in 24 hours, which is the maximum daily amount for this prcx:luct • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily wh le using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters• rash
If a 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, headache, rash, nausea or vomiting,consult a doctor promptly.
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 phannacist.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions,or Parkinson'sdisease),or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI,ask a doctor or pharmacist before taking this product.
• to make a childsleep_
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.
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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well
as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions do not take more than directed (see overdose warning)
- Do not exceed more than 6 doses in any 24-hour period
- Shake well before use
- measure only with dosing cup provided
- keep dosing cup with product
- mL=miliiter TSP=teaspoonful
- this adult product is not intended for use in children under 12 years of age
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INDICATIONS & USAGE SECTION
Uses
• temporarily relieves these common cold/flu symptoms:
• minor aches and pains• headache• sore throat• runny nose and sneezing • cough • relieves cough to help you get to sleep
• temporarily reduces fever.
INACTIVE INGREDIENT SECTION
Inactive ingredients: blue cohosh root extract, citric acid, echinacea root extract, eucalyptus oil, flavor, ginkgo 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, 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.
Ask a doctor or pharmacist before use if you are:
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers.
When using this product
When using this product • do not use more than directed
• excitability may occur, especially in children• marked drowsiness may occur • avoid alcoholic
drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a
motor vehicle or operating machinery.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have:
• liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis,or emphysema • a sodium-restricted diet.
OTC - STOP USE SECTION
Stop use and ask a doctor if • nervousness, dizziness, or
sleeplessness occur • pain or cough gets worse or lasts more than 7 days • new symptoms occur •fever gets worse or lasts more than 3 days • redness or swelling is present • cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1042675 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution | PSN | 6 |
| 1042675 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 6 |
| 1042675 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 6 |
| 1042675 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 6 |
| 1042675 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58593-003-06 | Rompe Pecho NTNT | 180 mL in 1 BOTTLE | LIQUID | 180 | 6 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Rompe Pecho NT NT
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- ACETAMINOPHEN
- POTASSIUM CITRATE ANHYDROUS
- CAULOPHYLLUM THALICTROIDES ROOT
- GLYCERIN
- ECHINACEA ANGUSTIFOLIA ROOT
- EUCALYPTUS OIL
- GINKGO BILOBA LEAF OIL
- GOLDENSEAL
- HONEY
- ANHYDROUS CITRIC ACID
- HOREHOUND
- MENTHOL
- METHYLPARABEN
- LICORICE
- MULLEIN LEAF
- POTASSIUM SORBATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- ULMUS RUBRA BARK
- SODIUM CHLORIDE
- PRUNUS SEROTINA BARK
- ZINC SULFATE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- MYRRH
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58593-003 | 58593-003-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 NT NT | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Efficient Laboratories Inc | 06faafaa-50a6-c16e-e063-6294a90a49cb | 2024-10-08 | Warnings | 58593-003-06 58593-003 58593000306 23fb59f8-53e6-1152-e063-6294a90a683c 06faafaa-50a6-c16e-e063-6294a90a49cb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

