Label: AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION- methenamine, sodium salicylate tablet
- NDC Code(s): 49973-011-04, 49973-011-18, 49973-011-24
- Packager: i-Health, Inc.
- Category: HUMAN OTC 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.
Drug Label Information
Updated December 12, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- INDICATIONS & USAGE
-
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
- have 3 or more alcoholic drinks every day while using this product
- have stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- take more or for a longer time than directed
Do not use:
- if you are on a sodium restricted diet
- if you are allergic to salicylates (including aspirin) unless directed by a doctor
- if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems unless directed by a doctor
Ask a doctor before use if you have
- frequent, burning urination for the first time
- the stomach bleeding warning applying to you
- history of stomach problems, such as heartburn
- high blood pressure
- heart disease
- liver cirrhosis
- bleeding problems
- diuretic use
- ulcers
- kidney disease
- reached age 60 or older
Ask a doctor or pharmacist before use if you are
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
Inactive Ingredients: Benzoic Acid, Cellulose, Croscarmellose Sodium, Edible black ink, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Hydroxypropyl Cellulose, Hydroxypropyl Methylcellulose, Magnesium Stearate, Methacrylic Acid - Ethyl Acrylate Copolymer, Silica, Stearic Acid, Titanium Dioxide, Triethyl Citrate
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION
methenamine, sodium salicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49973-011 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE 162 mg SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE 162.5 mg Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) POWDERED CELLULOSE (UNII: SMD1X3XO9M) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color red Score no score Shape ROUND Size 10mm Flavor Imprint Code AZOUD Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49973-011-24 1 in 1 BOX 03/01/2016 1 24 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:49973-011-18 1 in 1 BOX 04/23/2018 2 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:49973-011-04 4 in 1 POUCH; Type 0: Not a Combination Product 11/06/2015 01/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/06/2015 Labeler - i-Health, Inc. (061427694)
