ROMPE PECHO NT NT- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Rompe Pecho NT by

Drug Labeling and Warnings

Rompe Pecho NT by is a Otc medication manufactured, distributed, or labeled by Efficient Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose

Pain reliever/fever reducer

Cough Suppressant

Antihistamine

WARNINGS

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.

DO NOT USE

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_

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

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

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

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.

QUESTIONS

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:

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.

ASK DOCTOR

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.

STOP USE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROMPE PECHO NT  NT
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)
GLYCERIN (UNII: PDC6A3C0OX)
ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
GOLDENSEAL (UNII: ZW3Z11D0JV)
HONEY (UNII: Y9H1V576FH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HOREHOUND (UNII: K08036XEJV)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
LICORICE (UNII: 61ZBX54883)
MULLEIN LEAF (UNII: 9936O846LI)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
ZINC SULFATE (UNII: 89DS0H96TB)
MYRRH (UNII: JC71GJ1F3L)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-003-06	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/01/2023

Labeler - Efficient Laboratories Inc (969044932)

Registrant - Efficient Laboratories Inc (969044932)