Label: FOSTER AND THRIVE MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

  • NDC Code(s): 70677-1230-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 7, 2023

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  • Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 99.5 mg .

  • Purpose

    Urinary Analgesic

  • Warnings

    Do not exceed recommended dosage

    Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician

  • Ask doctor before use if you have

    ■ kidney disease
    ■ allergies to food, preservatives or dyes
    ■ had a hypersensitive reaction to phenazopyridine

  • 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 doctor if

    ■ your symptoms last for more than 2 days
    ■ you suspect you are having an adverse reaction to the medication

    Long-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,

    Ask a health professional before use.

  • Keep out of reach of children

    In case of an overdose, get medical help or contact a Poison Control Center right away.

  • Use

    Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract
    infections.

  • Inactive ingredients

    corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and triacetin

  • Directions


    ■ adults and children 12 years and over:
    take 2 tablets 3 times daily with a full glass of water, with or after meals as needed

    ■ children under 12 years: consult a doctor

    ■ Do not use for more than 2 days (12 tablets) without consulting a doctor

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    FOSTER AND THRIVE MAXIMUM STRENGTH URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1230
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorbrownScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code p99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1230-11 in 1 CARTON07/20/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/20/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Reese Pharmaceutical Co (004172052)
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