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
Updated March 25, 2014
If you are a consumer or patient please visit this version.
- 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 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 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)