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#

ProductRompe Pecho NT NT
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure15 sections

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
Age
  • Dose
  • adults and children 12 years of age and over
  • 30 mL every 4 hours
  • children under 12 years of age
  • do not use

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

www.efficientlabs.com

Distributed by

Efficient Laboratories, Inc., Miami, Fl 33166

Made in U.S.A.

Ask a doctor or pharmacist before use if you are:

OTC - ASK DOCTOR SECTION


Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION



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

labellabelPackPack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1042675acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral SolutionPSN6
1042675acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD6
1042675acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY6
1042675acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY6
1042675APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-003-06Rompe Pecho NTNT180 mL in 1 BOTTLELIQUID1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-003ROMPE PECHO NT NT (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [EFFICIENT LABORATORIES INC]6Current NDC, 1 package rows20241010_06faafaa-50a6-c16e-e063-6294a90a49cb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58593-00358593-003-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rompe Pecho NT NTACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEEfficient Laboratories Inc06faafaa-50a6-c16e-e063-6294a90a49cb2024-10-08WarningsExact identifier
ndc (package): 58593-003-06
ndc (product): 58593-003
ndc11 (package): 58593000306
spl id: 23fb59f8-53e6-1152-e063-6294a90a683c
spl set id: 06faafaa-50a6-c16e-e063-6294a90a49cb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.