Label: AZO URINARY TRACT HEALTH- phenazopyridine hydrochloride tablet
- NDC Code(s): 49973-760-12, 49973-760-24, 49973-760-30, 49973-760-32
- Packager: i-Health, Inc.
- Category: HUMAN PRESCRIPTION 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.
Updated March 25, 2014
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- ACTIVE INGREDIENT
Active Ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mgClose
Urinary tract analgesicClose
- INDICATIONS & USAGE
Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.Close
Please read insert for important precautions.
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride
- Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
- sensitivities to lactose
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 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.Close
- DOSAGE & ADMINISTRATION
- 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
- 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 degrees F) in a dry place and protect from light.
Tamper evident: Product is dealed within blisters. Do not use if any part of the blister is torn, open or damaged.Close
- INACTIVE INGREDIENT
Inactive ingredients Lactose, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, sodium starch glycolate and talc.Close
- PRINCIPAL DISPLAY PANEL
2 Solutions for Urinary Tract Health*
Urinary Tract Health
Urinary Pain Relief
- RELIEVES PAIN, BURNING AND URGENCY
- TARGETS THE SOURCE OF PAIN
MOST TRUSED #1 BRAND
95 mg Phenazopyridine Hydrochloride
- HELPS FLUSH TO MAINTAIN URINARY TRACT CLEANLINESS*
- WITH PROBIOTIC
*THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FDA. THIS IF NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
- INGREDIENTS AND APPEARANCE
AZO URINARY TRACT HEALTH
phenazopyridine hydrochloride tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49973-760 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 LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SHELLAC (UNII: 46N107B71O) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color brown (Maroon) Score no score Shape ROUND (Tablet) Size 7mm Flavor Imprint Code W Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49973-760-32 9 in 1 BOX 1 2 in 1 BLISTER PACK 2 NDC:49973-760-30 15 in 1 PACKAGE 2 2 in 1 BLISTER PACK 3 NDC:49973-760-24 12 in 1 PACKAGE 3 2 in 1 BLISTER PACK 4 NDC:49973-760-12 6 in 1 PACKAGE 4 2 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/28/2014 Labeler - i-Health, Inc. (061427694) Establishment Name Address ID/FEI Business Operations Contract Pharmacal Corporation 057795122 manufacture(49973-760)