Label: TOPCARE CHEST CONGESTION AND SINUS CONGESTION RELIEF PE- guaifenesin/phenylephrine tablet
- NDC Code(s): 36800-989-50
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- Uses
- Warnings
-
Do not use
■ this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the
MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health
professional. - Ask a doctor before use if you have
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TOPCARE CHEST CONGESTION AND SINUS CONGESTION RELIEF PE
guaifenesin/phenylephrine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-989 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE (UNII: J2B2A4N98G) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POVIDONE (UNII: FZ989GH94E) MAGNESIUM SILICATE (UNII: 9B9691B2N9) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code PH043 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-989-50 1 in 1 CARTON 06/05/2006 1 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/05/2006 Labeler - TOPCO ASSOCIATES LLC (006935977) Registrant - Reese Pharmaceutical Co (004172052)