AZO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [I-HEALTH, INC.]

AZO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [I-HEALTH, INC.]
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NDC 49973-761-30
Set ID b2c6bb64-bb81-413c-8a6b-0420d2573ab6
Category HUMAN OTC DRUG LABEL
Packager i-Health, Inc.
Generic Name
Product Class
Product Number
Application Number
  • Drug Facts

    Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 95 mg

  • PURPOSE

    Purpose

    Urinary tract analgesic

  • INDICATIONS & USAGE

    Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infection.

  • WARNINGS

    Warnings

    Please read insert for important precautions.

  • ASK DOCTOR

    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 USE

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

  • WHEN USING

    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

    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.
  • PREGNANCY OR BREAST FEEDING

    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

    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.
  • OTHER SAFETY INFORMATION

    Other Information

    • 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°-86°F) 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.

  • INACTIVE INGREDIENT

    Inactive ingredientsCorn starch, croscamellose sodium, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide and talc.

  • QUESTIONS

    Información y instrucciones en Español adjuntas

    Distributed by i-Health, Inc. 55 Sebethe Drive, Cromwell, CT 06416

    Country of origin: U.S.

    Size and color of tablets may vary.

    For questions, concerns, or to report an adverse event, call (800) 722-3476

    www.azoproducts.com

  • PRINCIPAL DISPLAY PANEL

    Fast Relief for Urinary Pain

    AZO

    Urinary Pain Relief

    VALUE SIZE

    • RELIEVES PAIN, BURNING & URGENCY
    • TARGETS THE SOURCE OF PAIN

    #1 MOST TRUSTED BRAND

    30 Tablets

    95 mg Phenazopyridine Hydrochloride

    Label

  • INGREDIENTS AND APPEARANCE
    AZO URINARY PAIN RELIEF  
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49973-761
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE95 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorbrown (Maroon) Scoreno score
    ShapeROUND (Tablet) Size7mm
    FlavorImprint Code W
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49973-761-3015 in 1 BOX11/01/201405/31/2020
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2014
    Labeler - i-Health, Inc. (061427694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corp.057795122manufacture(49973-761)