Label: GOOD REMEDIES MAXIMUM STRENGTH URINARY PAIN RELIEF CAPLET- phenazopyridine hydrochloride tablet, film coated

  • NDC Code(s): 70692-178-08
  • Packager: Strive Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 6, 2025

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  • Drug Facts

  • Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 99.5 mg

  • Purpose

    Urinary tract analgesic

  • Use

    Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
    Treatment should not exceed 2 days; see Directions.

  • Warnings

    Do not exceed recommended dosage

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

    Ask a doctor before use if you have • liver or kidney disease
    • allergies to foods, preservatives or dyes • had a hypersensitive reaction to Phenazopyridine Hydrochloride

    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.

    If pregnant or breastfeeding, 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 right away.

  • Directions

    Adults and children 12 years and over: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctorChildren under 12 years: Do not use without consulting a doctor

  • Other information

    Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
    • 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.
    • Store at room temperature between 20°C-25°C (68°F -77°F) in a dry place and protect from light.

  • Inactive ingredients

    colloidal silicone dioxide, gum acacia extra pure, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate.

  • Questions or comments?

    1-888-577-8033 Monday - Friday 8am - 4pm EST

  • SPL UNCLASSIFIED SECTION

    Compare to the active ingredient in AZO Urinary Pain Relief® Maximum Strength*

    Maximum strength UTI pain reliever available without a prescription

    Helps provide relief for:urinary pain and burning

    Among our over the counter urinary pain relief products

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

    Distributed by: Strive Pharmaceuticals, Inc.
    East Brunswick, NJ 08816

    PRODUCT OF INDIA

    *This product is not manufactured or distributed by i-Health Inc., distributor of AZO Urinary Pain Relief®.

    WARNING: This product can expose you to Phenazopyridine Hydrochloride, which is known to the state of California to cause cancer. For more information, visit www.p65warnings.ca.gov

  • Packaging

    Good Remedies Maximum Strength Urinary Pain Relief Caplet

  • INGREDIENTS AND APPEARANCE
    GOOD REMEDIES MAXIMUM STRENGTH URINARY PAIN RELIEF CAPLET 
    phenazopyridine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-178
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ACACIA (UNII: 5C5403N26O)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorbrownScoreno score
    ShapecapsuleSize9mm
    FlavorImprint Code S160
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-178-081 in 1 CARTON01/06/2025
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/06/2025
    Labeler - Strive Pharmaceuticals Inc. (080028013)