PHENYLEPHRINE HYDROCHLORIDE tablet
Phenylephrine Hydrochloride by
Drug Labeling and Warnings
Phenylephrine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by InvaTech Pharma Solutions LLC, Elysium Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 57631-018 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 10 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color red Score no score Shape ROUND Size 7mm Flavor Imprint Code S08 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 57631-018-00 30000 in 1 DRUM; Type 0: Not a Combination Product 01/13/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/13/2021 Labeler - InvaTech Pharma Solutions LLC (078602180) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceuticals Ltd 915664486 manufacture(57631-018)
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