Label: URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/12

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  • Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 95 mg

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  • Purpose

    Urinary analgesic

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  • Uses

    for temporary relief of

    • urinary pain
    • burning
    • urgency
    • frequency associated with urinary tract infection
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  • Warnings

    Do not use

    for more than 2 days without consulting a doctor.

    Ask a doctor before use if you have

    • kidney disease
    • hepatic or renal problems
    • allergies to foods, preservatives, or dyes
    • previously exhibited hypersensitivity to Phenazopyridine.

    Stop use and ask a doctor if

    • symptoms persists for more than 2 days
    • yellowish tinge of skin or sclera occurs

    When using this product

    • stomach upset may occur
    • a harmless reddish- orange color will be produced in the urine and may stain fabric
    • staining of the contact lenses may also occur

    If pregnant or breast- feeding

    Ask a health care professional before use.

    Keep out of reach of children.

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

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  • Directions

    • adults and children 12 years of age and over: take 2 tablets 3 times per day with or after meals as needed. Take with a full glass of water.
    • children under 12 years of age: consult a doctor
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  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • do not use if cellophane packet is torn or open
    • *This product is not manufactured or distributed by Amerifit Brands, Inc., the distributor of AZO Standard®.
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  • Inactive ingredients

    lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze and sodium starch glycolate

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  • Principal Display Panel

    Compare to AZO STANDARD® active ingredient*

    Urinary Pain Relief

    Phenazopyridine HCl

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Another quality product Distributed by McKesson

    One post street, San Franciso, CA 94104 

    Money back guarantee

    Please visit us at www.sunmarkbrand.com

    Sunmark urinary pain relief

    Phenazopyridine Hydrochloride 95 mg

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  • INGREDIENTS AND APPEARANCE
    URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-364(NDC:10267-0064)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    MAGNESIUM SILICATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SHELLAC  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code CPC64
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-364-44 1 in 1 CARTON
    1 30 in 1 CELLO PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 07/09/2010
    Labeler - Mckesson (Sunmark) (177667227)
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