Label: CHEEKY BONSAI UTI PAIN RELIEF- phenazopyridine hydrochloride tablet
- NDC Code(s): 81860-113-24
- Packager: IXXA, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 29, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Warnings
- Ask doctor before use if you have
- When using this product
-
Stop use and ask 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 reach of children
- Use
- Inactive ingredients
- Directions
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CHEEKY BONSAI UTI PAIN RELIEF
phenazopyridine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81860-113 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TALC (UNII: 7SEV7J4R1U) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color brown Score no score Shape OVAL Size 9mm Flavor Imprint Code p99 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81860-113-24 1 in 1 CARTON 05/12/2021 1 24 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 05/12/2021 Labeler - IXXA, INC (117979157) Registrant - Reese Pharmaceutical Co (004172052)