ROMPE PECHO MAX MULTI SYMPTOMS- acetaminophen, dextromethophan hbr, phenylephrine hcl, guaifenesin liquid

Rompe Pecho Max Multi Symptoms by

Drug Labeling and Warnings

Rompe Pecho Max Multi Symptoms by is a Otc medication manufactured, distributed, or labeled by EFFICIENT LABORATORIES INC, Pharmalab Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

• Pain reliever/fever reducer
• Cough suppressant
• Expectorant
• Nasal decongestant

INDICATIONS & USAGE

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

Warning

Do not exceed recommended dosage.

• Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlgem(mucus) unless directed by a doctor.

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

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.

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 a pharmacist.
• Do not take this product for 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 now 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.

ASK DOCTOR/PHARMACIST

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

STOP USE

Stop use and ask a doctor if

• a symptoms do not improve within 7 days, tends to recur, or is 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.

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.

• In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• shake well before use 
• do not exceed more than 6 doses in any 24 hour period or as directed by a doctor
• adults and children 2 years of age and over: 20 mL (4 teaspoonful) every 4 hours
• children under 12 years of age: consult a docotr

INACTIVE INGREDIENT

Inactive ingreadients:

Blue cohosh, citirc acid, echinacea, eucalptus oil, ginko biloba, glycerin, golden seal root, honey, horehound herb, licorice root, menthol, methylparaben, mullein leaves, myrrh, potassium citrate, potassium sorbate, propylene  glycol, propylparaben, slippery elm bark, sodium chloride, suralose, water, wild cherry bark, zinc sulfate

QUESTIONS

Questions or comments?

Call (305) 805-3456

Monday-Friday 9 am- 5 pm EST or www.efficientlabs.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROMPE PECHO MAX MULTI SYMPTOMS 
acetaminophen, dextromethophan hbr, phenylephrine hcl, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-828
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GINKGO (UNII: 19FUJ2C58T)
GLYCERIN (UNII: PDC6A3C0OX)
GOLDENSEAL (UNII: ZW3Z11D0JV)
HONEY (UNII: Y9H1V576FH)
HOREHOUND (UNII: K08036XEJV)
LICORICE (UNII: 61ZBX54883)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
MULLEIN LEAF (UNII: 9936O846LI)
MYRRH (UNII: JC71GJ1F3L)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
ZINC SULFATE (UNII: 89DS0H96TB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-828-08	1 in 1 CARTON	01/01/2014
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2014

Labeler - EFFICIENT LABORATORIES INC (969044932)