Label: MUCOSA- guaifenesin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50436-6232-2 - Packager: Unit Dose Services
- This is a repackaged label.
- Source NDC Code(s): 49483-272
- 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 July 19, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- WARNINGS
- HOW SUPPLIED
- MUCUS RELIEF (GUAIFENESIN) TABLET
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INGREDIENTS AND APPEARANCE
MUCOSA
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-6232(NDC:49483-272) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code TCL272 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50436-6232-2 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/16/2012 Labeler - Unit Dose Services (831995316) Establishment Name Address ID/FEI Business Operations Unit Dose Services 831995316 REPACK(50436-6232) , RELABEL(50436-6232)