Rompe Pecho DM

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Efficient Laboratories Inc
NDC Code: 58593-275

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 Hydrobromide 10 mg ...................................... Cough Suppressant

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

Purpose

Cough Suppressant

Expectorant

Uses:

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus and make cough more productive.
  • Temporarily relieves cough due to the common cold or inhaled irritants.

Warnings

A persistent cough may be a sign of a serious condition.

Do not exceed recommended dosage


Do not use

  • 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 on MAOI, ask a doctor or pharmacist before taking this product.  
  • if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
  • 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.

  • Stop use and ask a doctor
  • If cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache.
  • these could 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Shake well before use

Do not exceed 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

Inactive Ingredients:Bio Propolis, Blue Cohosh, Echinacea, Eucalyptus, Gingka Biloba, Golden Seal Root, Honey, Licorice Root, Menthol, Methylparaben, Mullein, Myrrh, Pleurisy Root, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Slippery Elm Bark, Sodium Chloride, Spearmint, 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  DM
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-275
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
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE 
PROPOLIS WAX 
CAULOPHYLLUM THALICTROIDES ROOT 
ECHINACEA, UNSPECIFIED 
EUCALYPTUS GLOBULUS LEAF 
GINKGO 
GOLDENSEAL 
HONEY 
GLYCYRRHIZA GLABRA 
MENTHOL 
METHYLPARABEN 
VERBASCUM DENSIFLORUM LEAF 
MYRRH 
ASCLEPIAS TUBEROSA ROOT 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
ULMUS RUBRA BARK 
SODIUM CHLORIDE 
SPEARMINT 
PRUNUS SEROTINA BARK 
ZINC SULFATE 
Packaging
#Item CodePackage Description
1NDC:58593-275-06178 mL in 1 BOTTLE
2NDC:58593-275-1010 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2001
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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