Label: URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet
- NDC Code(s): 49348-364-44
- Packager: Mckesson (Sunmark)
- This is a repackaged label.
- Source NDC Code(s): 10267-0064
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated October 3, 2012
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- Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mgClose
for temporary relief of
- urinary pain
- frequency associated with urinary tract infection
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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away
- 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
- 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®.
- Inactive ingredients
lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze and sodium starch glycolateClose
- Principal Display Panel
Compare to AZO STANDARD® active ingredient*
Urinary Pain Relief
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Phenazopyridine Hydrochloride 95 mg
- INGREDIENTS AND APPEARANCE
URINARY PAIN RELIEF
phenazopyridine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-364(NDC:10267-0064) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM SILICATE (UNII: 9B9691B2N9) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SHELLAC (UNII: 46N107B71O) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) 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)