Label: REFENESEN CHEST CONGESTION RELIEF- guaifenesin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 10956-788-01, 10956-788-09, 10956-788-50 - Packager: Reese Pharmaceutical Co
- 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 1, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- Ask a Doctor before use if you have
- STOP USE
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
REFENESEN CHEST CONGESTION RELIEF
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10956-788 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, COLLOIDAL (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MALTODEXTRIN (UNII: 7CVR7L4A2D) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code PH063 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10956-788-01 1 in 1 CARTON 1 NDC:10956-788-50 50 in 1 BOTTLE, PLASTIC 2 NDC:10956-788-01 1 in 1 CARTON 2 NDC:10956-788-09 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/23/2003 Labeler - Reese Pharmaceutical Co (004172052) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Reese Pharmaceutical Co 004172052 relabel, repack Establishment Name Address ID/FEI Business Operations Pharbest 557054835 manufacture