Label: URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet
- NDC Code(s): 73581-909-72
- Packager: YYBA CORP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 3, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Please read insert for important precautions.
Ask a doctor before use if you have:
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine Hydrochloride
Do not useif you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
When using this product
■ stomach upset may occur, taking this product with or after meals may reduce stomach upset
■ your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.
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 medication
■ Long-term adminitration of phenazopyridine hydrochloride has induced neoplasia in rats (large instestine) andmice (liver). Although no association between phenazopyridine hydrochloride and human enoplasia has beeen reported, adequate epidemiological studies along these lines have not been conducted.
If pregnant or breast-feeding,ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.
Keep out of reach of children.In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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OTHER SAFETY INFORMATION
■ This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
■ This product may stain contact lenses and other items if handled after touching tablets
■ long term administration of phenazopyridine HCI 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
■ Store at room temperature 15°-30°C (59°-86°F) in a dry place and protect from light
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
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INGREDIENTS AND APPEARANCE
URINARY PAIN RELIEF
phenazopyridine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73581-909 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 MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color brown Score no score Shape ROUND Size 7mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73581-909-72 72 in 1 BOTTLE; Type 0: Not a Combination Product 09/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/10/2020 Labeler - YYBA CORP (006339772)