Label: PHENAZOPYRIDINE HYDROCHLORIDE tablet

  • NDC Code(s): 70985-029-09, 70985-029-13
  • Packager: Drug Ocean LLC
  • 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 March 27, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 99.5 mg

  • PURPOSE

    Purpose

    Urinary tract analgesic

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings

    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 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 healthcare professional before use. A pregnancy test and consultation with a healthcare 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 12 years and older: 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 doctor. 
    • Children under 12: Do not use without consulting a doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients  carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.

  • OTHER SAFETY INFORMATION

    Other Information

    • This product contains Phenazopyridine Hydrochloride, known to the State of California to cause cancer
    • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
    • This product may stain soft contact lenses and other items if handled after touching tablets
    • Store at room temperature (59 o-86 oF) in a dry place and protect from light.

    Tamper evident:Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.

  • SPL UNCLASSIFIED SECTION

    Questions or comments? Call 1-844-200-6566

    Distributed by:
    Drug Ocean LLC
    1 Bridge Plaza, North Central Road,
    6th Floor, Suite 675,
    Fort Lee, NJ 07024


    Made in India


    Mfg License Code:
    RA/Drug/RAJ.-1750

    ORG 03/2024

  • Packaging

    Drug Ocean NDC 70985- 029-09

    Phenazopyridine Hydrochloride Tablets, 99.5 mg

    Urinary Tract Pain Relief

    • Relieves Pain, Burning and Urgency
    • Targets the source of Pain

    12 Tablets

    Phenazopyridine HCl Tablet 99.5mg-Carton

    Blister Label

    Phenazopyridine HCl Tablet 99.5mg-Blister

  • Packaging

    Drug Ocean NDC 70985- 029-13

    Phenazopyridine Hydrochloride Tablets, 99.5 mg

    Urinary Tract Pain Relief

    • Relieves Pain, Burning and Urgency
    • Targets the source of Pain

    24 Tablets

    Phenazopyridine HCl Tab-Carton-24 T

    Blister Label

    Phenazopyridine HCl Tab-Blister-24 T

  • INGREDIENTS AND APPEARANCE
    PHENAZOPYRIDINE HYDROCHLORIDE 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70985-029
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorred (Maroon) Scoreno score
    ShapeCAPSULESize9mm
    FlavorImprint Code p99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70985-029-091 in 1 CARTON03/12/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70985-029-131 in 1 CARTON03/12/2024
    224 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/12/2024
    Labeler - Drug Ocean LLC (080381835)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!