Label: RUGBY PHENAZOPYRIDINE HCL URINARY TRACT ANALGESIC- phenazopyridine hydrochloride tablet
- NDC Code(s): 0536-1411-07
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 18, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warning
- Ask Doctor before use if you have
- When using this product
-
Stop use and ask a doctor if
■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medicationLong-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
- If pregnant or breast feeding
- Keep out of the reach of children
- Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RUGBY PHENAZOPYRIDINE HCL URINARY TRACT ANALGESIC
phenazopyridine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1411 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color red Score no score Shape ROUND Size 7mm Flavor Imprint Code P95 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1411-07 1 in 1 CARTON 12/07/2023 1 30 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 unapproved drug other 12/07/2023 Labeler - Rugby Laboratories (079246066) Registrant - Reese Pharmaceutical Co (004172052)