Label: TOPCARE CHEST CONGESTION RELIEF- guaifenesin tablet
- NDC Code(s): 36800-794-50
- Packager: TOPCO ASSOCIATES LLC
- 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 December 29, 2022
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- 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
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INGREDIENTS AND APPEARANCE
TOPCARE CHEST CONGESTION RELIEF
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-794 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:36800-794-50 1 in 1 CARTON 12/01/2013 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/01/2012 Labeler - TOPCO ASSOCIATES LLC (006935977) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Pharbest 557054835 manufacture(36800-794)