ROMPE PECHO  SF- 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 Ingredient (In each 5ml teaspoonful)................. Purpose


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


Purpose

Expectorant


Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome
mucus

Warnings
Do not exceed recommended dosage.

Ask a doctor before use if you have

Stop use and ask a doctor if
cough persists for more than 1 week, tends to recur, or is accompainied by a fever, rash or persistent headache. A persistent cough may be a sign of serious condition.


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


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

Directions:Shake well before use. Do not exceed 6 doses in any 24 hour period or as directed by a doctor

 AgeDose
adults and children 12 years of age and over 10 mL (2tsps) 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 

Inactive Ingredients:

Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerin, Golden Seal Root extract, Honey Flavor, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate, 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-5PM EST

www.efficientlabs.com

rompepechosflabel

ROMPE PECHO   SF
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-265
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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GINKGO (UNII: 19FUJ2C58T)  
GLYCERIN (UNII: PDC6A3C0OX)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
HOREHOUND (UNII: K08036XEJV)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
VERBASCUM DENSIFLORUM LEAF (UNII: 9936O846LI)  
MYRRH (UNII: JC71GJ1F3L)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC SULFATE (UNII: 89DS0H96TB)  
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorHONEY (Honey Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58593-265-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
2NDC:58593-265-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/1999
Labeler - Efficient Laboratories, Inc. (969044932)
Establishment
NameAddressID/FEIBusiness Operations
Pharmalab Enterprises, Inc.174401088manufacture(58593-265)

Revised: 12/2021
Document Id: d242fd7f-bdfb-2acd-e053-2995a90abc5e
Set id: 31ff48fc-9603-413c-ab7c-2598b3e08f9c
Version: 7
Effective Time: 20211203
 
Efficient Laboratories, Inc.