UTI INFECTION CONTROL- methenamine, sodium salicylate tablet

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient (in each tablet)

Methenamine 162 mg
Sodium Salicylate 162.5 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Antibacterial
Analgesic (pain reliever)

Uses

Temporarily relieves:

• pain and burning
• frequency and urgency of urination

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 a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

• are 60 or older
• have stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
  
• 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
  
• take more or for a longer time than directed
  

Do Not Use:

if you are allergic to salicylates (including aspirin)

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
  
• a sodium restricted diet
  
• reached age 60 or older
  

Ask a doctor or pharmacist before use if you are:

• taking any other drug containing an NSAID (prescription or non-prescription)
• taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug

When using this product:

• do not take more than the recommended dosage

Stop use and ask a doctor if:

• product has been used for 3 days
• ringing in the ears
• you experience any of the following signs of stomach bleeding: feel faint
  
• vomit blood
  
• have bloody or black stool
  
• have stomach pain that gets worse or lasts
  

If pregnant or breastfeeding

ask a health professional before use. It is especially important not to use this product (which contains sodium salicylate) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222.

Directions

Adults and children 12 years and over:

• take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids.
• Do not use for more than a 3 day period unless directed by a doctor.

Children under 12 years:

• ask a doctor.

Other information

• each tablet contains 24.4 mg of sodium
• store at 59-86°F (15-30°C) in a dry place
• protect from light
  
• Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.
  

Inactive Ingredients

benzoic acid, croscarmellose sodium, fd&c red #40, fd&c yellow #6, hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, silicon dioxide, stearic acid, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

MANUFACTURED FOR

Cadence OTC, Oakland, CA 94612

Questions or comments:

Call 1-877-862-7455 or visit us at cadenceotc.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CadenceOTC

UTI
INFECTION
CONTROL

Antibacterial to help
control a UTI

METHENAMINE AND SODIUM SALICYLATE (NSAID)

2 day supply
12 tablets

NOT INTENDED TO REPLACE MEDICAL CARE.

CSDUALCAD
Rev 1/26

INGREDIENTS AND APPEARANCE

UTI INFECTION CONTROL 
methenamine, sodium salicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73436-1221
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	PH061
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73436-1221-2	1 in 1 CARTON	04/15/2026
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/06/2026

Labeler - CADENCE HEALTH, INC. (116830263)