Label: MUCUS RELIEF- guaifenesin tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 58118-9896-3, 58118-9896-6, 58118-9896-9 - Packager: Clinical Solutions Wholesale
- 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 November 20, 2013
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
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- Principal Display Panel
- Principal Display Panel
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58118-9896(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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code TCL272 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58118-9896-3 30 in 1 BOTTLE, PLASTIC 2 NDC:58118-9896-6 60 in 1 BOTTLE, PLASTIC 3 NDC:58118-9896-9 90 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/23/2012 Labeler - Clinical Solutions Wholesale (078710347) Registrant - Clinical Solutions Wholesale (078710347) Establishment Name Address ID/FEI Business Operations Clinical Solutions Wholesale 078710347 REPACK(58118-9896) , RELABEL(58118-9896)