Rompe Pecho CF

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 5mL
Labeler: Efficient Laboratories Inc
NDC Code: 58593-235

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

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.



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 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 persistent cough may be a sign of a serious condition.

Do not exceed the recommended dosage


Stop use and ask doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or is accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache
  • a persistent cough may be a sign of a serious condition

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


Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 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                                Do not use

Uses

  • temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
  • temporary relief of cough due to minor throat and bronchial irritation
  • helps to control reflex that causes coughing


Inactive Ingredients:Blue Cohosh, Echinacea, Eucalyptus Oil, Ginkgo Biloba, Golden Seal, Honey, Horehound
Herb, Licorice Root, Menthol, Methylparaben, Mullein, Myrrh, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified
Water, Slippery Elm Bark, Sodium Chloride, Sucralose, Wild Cherry Bark and Zinc Sulfate.

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.

ROMPE PECHO  CF
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-235
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE 
HOREHOUND 
CAULOPHYLLUM THALICTROIDES ROOT 
ECHINACEA, UNSPECIFIED 
EUCALYPTUS GLOBULUS LEAF 
GINKGO 
GOLDENSEAL 
HONEY 
GLYCYRRHIZA GLABRA 
MENTHOL 
METHYLPARABEN 
VERBASCUM DENSIFLORUM LEAF 
MYRRH 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
ULMUS RUBRA BARK 
SODIUM CHLORIDE 
PRUNUS SEROTINA BARK 
ZINC SULFATE 
Packaging
#Item CodePackage Description
1NDC:58593-235-06178 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2007
Labeler - Efficient Laboratories Inc (969044932)
Registrant - Efficient Laboratories Inc (969044932)

Revised: 12/2013
 
Efficient Laboratories Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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