Label: TOPCARE NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet, film coated
- NDC Code(s): 36800-094-23, 36800-094-47, 36800-094-68, 36800-094-89
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated November 16, 2021
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- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
TOPCARE NASAL DECONGESTANT PE
phenylephrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-094 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color RED Score no score Shape ROUND Size 8mm Flavor Imprint Code L7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-094-23 12 in 1 CARTON 09/19/2005 01/31/2022 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:36800-094-47 1 in 1 CARTON 02/03/2009 07/02/2011 2 150 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:36800-094-68 6 in 1 CARTON 09/13/2005 3 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:36800-094-89 3 in 1 CARTON 09/12/2005 4 6 in 1 BLISTER PACK; 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 09/12/2005 Labeler - Topco Associates LLC (006935977)