WALGREENS ANTIBACTERIAL PLUS URINARY PAIN RELIEF (METHENAMINE, SODIUM SALICYLATE) TABLET [WALGREEN COMPANY]

WALGREENS ANTIBACTERIAL PLUS URINARY PAIN RELIEF (METHENAMINE, SODIUM SALICYLATE) TABLET [WALGREEN COMPANY]
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NDC 0363-4404-24
Set ID 49e6ac45-13d0-4874-b0e1-e276a00304f7
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number
  • 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
    WALGREENS ANTIBACTERIAL PLUS URINARY PAIN RELIEF 
    methenamine, sodium salicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4404
    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:0363-4404-241 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 - Walgreen Company (008965063)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052repack(0363-4404) , relabel(0363-4404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest557054835manufacture(0363-4404)

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