Label: CVS ANTIBACTERIAL PLUS URINARY PAIN RELIEF- methenamine, sodium salicylate tablet

  • 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 January 17, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients (in each tablet):

    Methenamine 162 mg

    Sodium Salicylate 162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug)

  • Purpose

    Antibacterial

    Analgesic (pain reliever)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Uses Temporarily relieves: pain & 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 behaviour 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

    When using this product • do not take more than the recommended dosage

    Stop and ask a doctor if

    • product has been used for 3 days

    • you experience any of the following signs of stomach bleeding:

    • feel faint, vomit blood • have bloody or black stools • have stomach pain that does not get better

    • ringing in the ears or a loss of hearing occurs

    If pregnant or breast feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    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. Children under 12 years: ask a doctor

  • INACTIVE INGREDIENT

    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

  • STORAGE AND HANDLING

    Other Information: • each tablet contains 25 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.

  • SPL UNCLASSIFIED SECTION

    • HELPS CONTROL THE INFECTION*
    • PLUS GENERAL PAIN RELIEVER

    Antibacterial Urinary Pain Relief

    Methenamine and Sodium Salicylate (NSAID)

  • Packaging

    carton

  • INGREDIENTS AND APPEARANCE
    CVS ANTIBACTERIAL PLUS URINARY PAIN RELIEF 
    methenamine, sodium salicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-314
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE162 mg
    SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE162.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (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
    ColorredScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code PH061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-314-241 in 1 CARTON02/22/2017
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/22/2017
    Labeler - CVS Pharmacy, Inc (062312574)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052repack(69842-314) , relabel(69842-314)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest557054835manufacture(69842-314)