DOSAGE & ADMINISTRATION SECTION.
Directions: Adults and children 12 years and over: take tablets with full glass of water times day. Drink plenty of fluids. Children under 12 years: ask doctor.
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INACTIVE INGREDIENT SECTION.
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.
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INDICATIONS & USAGE SECTION.
Uses Temporarily relieves: pain burning frequency and urgency of urination.
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OTC - ACTIVE INGREDIENT SECTION.
Active Ingredients (in each tablet):. Methenamine 162 mgSodium Salicylate 162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug).
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.
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OTC - PURPOSE SECTION.
Purpose. AntibacterialAnalgesic (pain reliever).
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Packaging. carton.
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SPL UNCLASSIFIED SECTION.
Drug Facts.
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STORAGE AND HANDLING SECTION.
Other Information: each tablet contains 25 mg of sodium store at 59-86F (15-30C) in dry place protect from light Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.
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WARNINGS SECTION.
Warnings. Reyes 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 doctor because these symptoms could be an early sign of Reyes syndrome, rare but serious illness.Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:o take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)o have or more alcoholic drinks every day while using this producto have stomach ulcers or bleeding problems take blood thinning (anticoagulant) or steroid drugo are age 60 or older take more or for longer time than directedDo not use:o if you are on sodium restricted dieto if you are allergic to salicylates (including aspirin) unless directed by doctoro 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 doctorAsk doctor before use if you haveo frequent, burning urination for the first time the stomach bleeding warning applying to youo history of stomach problems, such as heartburno high blood pressure heart disease liver cirrhosis bleeding problemso diuretic use ulcers kidney disease reached age 60 or olderAsk doctor or pharmacist before use if you areo taking any other drug containing an NSAID (prescription or nonprescription)o taking blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drugWhen using this product do not take more than the recommended dosageStop and ask doctor ifo product has been used for dayso you experience any of the following signs of stomach bleeding:o feel faint, vomit blood have bloody or black stools have stomach pain that does not get bettero ringing in the ears or loss of hearing occursIf pregnant or breast feeding, ask health professional before use.
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