Label: SELECT BRAND COUGHTAB 400- guaifenesin tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 15127-151-01, 15127-151-50 - Packager: Select Brand Distributors
- Category: HUMAN OTC DRUG LABEL
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 October 1, 2014
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- Uses
- Warnings
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SELECT BRAND COUGHTAB 400
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-151 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 MALTODEXTRIN (UNII: 7CVR7L4A2D) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) COPOVIDONE (UNII: D9C330MD8B) MAGNESIUM STEARATE (UNII: 70097M6I30) 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:15127-151-50 1 in 1 CARTON 1 50 in 1 BOTTLE, PLASTIC 2 NDC:15127-151-01 1 in 1 CARTON 2 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/01/2012 Labeler - Select Brand Distributors (043562370) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Reese Pharmaceutical Co 004172052 relabel(15127-151) , repack(15127-151) Establishment Name Address ID/FEI Business Operations Pharbest 557054835 manufacture(15127-151)