ROMPE PECHO CF- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Rompe Pecho by

Drug Labeling and Warnings

Rompe Pecho 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 teaspoonful 5 ml.)                                Purpose

Dextromethorphan HBr 10 mg ...................................... Cough Suppressant

Guaifenesin 100 mg ................................................................... Expectorant

Phenylephrine HCL  5 mg .................................................... Nasal Decongestant

PURPOSE

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

WARNINGS

Warnings

Do not exceed recommended dosage.

Do not use

• 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 your doctor or pharmacist before taking this product.

DO NOT USE

Ask a doctor before use if you have
heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

a persistant or chronic cough

• a cough that is accompanied by excessive phlegm (mucus)

a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask doctor if

• symptoms do not improve within 7 days or is accompanied by a fever, rash, or persistent headache. A persistent cough may be sign of a serious condition.
• nervousness, dizziness, or sleeplessness occurs

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 accidental 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.

• Age: Dose
• adults and children 12 years of age and over: 10 mL (2 tsps) every 4 hours
• children 6 to under 12 years of age: 5 mL (1 tsp) every 4 hours
• children under 6 years of age: consult a doctor

INDICATIONS & USAGE

Uses

• temporarily relieves cough and nasal congestion as may occur with the common cold
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.

INACTIVE INGREDIENT

Inactive Ingredients:Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROMPE PECHO  CF
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-235
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
HOREHOUND (UNII: K08036XEJV)
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
GINKGO (UNII: 19FUJ2C58T)
GOLDENSEAL (UNII: ZW3Z11D0JV)
HONEY (UNII: Y9H1V576FH)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
VERBASCUM DENSIFLORUM LEAF (UNII: 9936O846LI)
MYRRH (UNII: JC71GJ1F3L)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-235-06	178 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2007
2	NDC: 58593-235-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015
3	NDC: 58593-235-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015
4	NDC: 58593-235-29	296 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	01/01/2015
5	NDC: 58593-235-10	10 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2007

Labeler - Efficient Laboratories Inc (969044932)

Registrant - Efficient Laboratories Inc (969044932)