ROMPE PECHO- guaifenesin liquid 
Efficient Laboratories Inc

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.

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Drug Facts

Active Ingredients:(in each teaspoonful 5 ml.)                                Purpose

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

Purpose

Expectorant

Uses:

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus and make cough more productive.

Warnings

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

Do not exceed recommended dosage.

Do not use

  • 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.

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 (2tsps) every 4 hrs.

children 6 to under 12 years of age            5 mL (1 tsp) every 4 hrs

children under 6 years of age                     Do not use

Inactive Ingredients:

Blue Cohosh, Echinacea, Eucalyptus Oil, Ginkgo Biloba, Golden Seal Root,
Honey, Horehound Herb, Licorice Root, Menthol, Methylparaben, Mullein, Myrrh, Potassium Sorbate, Propylene
Glycol, Propylparaben, Slippery Elm Bark, Sodium Chloride,Sucralose, Water, 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.

rompepechoRegLabel

ROMPE PECHO 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-245
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
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)  
ASCLEPIAS TUBEROSA ROOT (UNII: 1ZL82U5D18)  
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)  
HOREHOUND (UNII: K08036XEJV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58593-245-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199812/31/2015
2NDC:58593-245-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199812/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/199812/31/2015
Labeler - Efficient Laboratories Inc (969044932)

Revised: 4/2017
 
Efficient Laboratories Inc