Label: GUIAFENESIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 11534-164-01 - Packager: Sunrise Pharmaceutical Inc
- 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 29, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS AND USAGE
- WARNINGS
- OTC - STOP USE AND ASK A DOCTOR IF
- OTC – IF PREGNANT OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GUIAFENESIN
guiafenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11534-164 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) MALTODEXTRIN (UNII: 7CVR7L4A2D) Product Characteristics Color WHITE Score no score Shape ROUND Size 13mm Flavor Imprint Code TCL;272 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11534-164-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/08/2005 Labeler - Sunrise Pharmaceutical Inc (168522378) Registrant - Sunrise Pharmaceutical Inc (168522378)