PALATOS EXPECTORANTE- guaifenesin liquid 
All Pharma, LLC

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.

Palatos

Label Image
PALATOS EXPECTORANTE 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53149-2000
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, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
VERBASCUM DENSIFLORUM 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, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53149-2000-61 in 1 BOX01/01/2019
1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2019
Labeler - All Pharma, LLC (117605075)
Establishment
NameAddressID/FEIBusiness Operations
All Pharma, LLC117605075MANUFACTURE(53149-2000)

Revised: 12/2021
Document Id: 9c51c482-adea-4b02-b5fd-ac52ddbdd22c
Set id: d7786e19-8809-469c-8e84-761f231268e1
Version: 3
Effective Time: 20211231
 
All Pharma, LLC