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
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.
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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 DEA Schedule 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)