ROMPE PECHO CF- dextromethorphan hbr, guaifenesin, phenylephrine hcl 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

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 exceed recommended dosage.

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


Stop use and ask doctor if

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 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 

Uses

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 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.

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ROMPE PECHO  CF
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-235
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58593-235-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2007
2NDC:58593-235-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
3NDC:58593-235-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
4NDC:58593-235-29296 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package01/01/2015
5NDC:58593-235-1010 mL in 1 POUCH; Type 0: Not a Combination Product01/01/2019
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: 12/2019
Document Id: 63807fd9-0e80-4801-b061-28fa346575ea
Set id: 96c4dee1-6e66-4442-a7e3-56e874414c17
Version: 11
Effective Time: 20191229
 
Efficient Laboratories Inc