BRONCOMAR SF- guaifenesin liquid 
Gadal 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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Acvtive ingredients: (in each 5ml)              Purpose

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

Purpose

Expectorant

Uses

Warnings

Do not exceed recommended dosage

Do not use

Ask the doctor before use if you have

Stop use and ask the doctor if

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

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 tsps) every 4 hours

Children under 6 years of age                       Do not use

Inactive ingredients

Blue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, glycerin, gold seal root, honey flavor, horehound herb, licorice root, menthol, mullein, myrrh, potassium sorbate, slippery elm bark, sodium benzoate, propylene glycol, water, sodium chloride, sucralose, wild cherry bark and zinc sulfate.

BroncomarSF

BRONCOMAR  SF
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-218
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
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
EUCALYPTUS CAMALDULENSIS LEAF OIL (UNII: SN6D1J15I6)  
GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
HOREHOUND (UNII: K08036XEJV)  
LICORICE (UNII: 61ZBX54883)  
MENTHOL (UNII: L7T10EIP3A)  
MULLEIN LEAF (UNII: 9936O846LI)  
MYRRH (UNII: JC71GJ1F3L)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
ZINC SULFATE (UNII: 89DS0H96TB)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-218-061 in 1 CARTON
1177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2014
Labeler - Gadal Laboratories Inc (841305639)

Revised: 6/2014
Document Id: 1f890f7c-0ae0-4746-ad5e-de73ba503801
Set id: 01bae271-502b-4345-b114-0072c39b4dba
Version: 1
Effective Time: 20140612
 
Gadal Laboratories Inc