Label: PALATOS EXPECTORANTE- guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 53149-2000-6 - Packager: All Pharma, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 31, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
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
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INGREDIENTS AND APPEARANCE
PALATOS EXPECTORANTE
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53149-2000 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:53149-2000-6 1 in 1 BOX 01/01/2019 1 177 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2019 Labeler - All Pharma, LLC (117605075) Establishment Name Address ID/FEI Business Operations All Pharma, LLC 117605075 MANUFACTURE(53149-2000)