- Drug Facts
- Active Ingredients (in each tablet):
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
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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
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
WALGREENS ANTIBACTERIAL PLUS URINARY PAIN RELIEF
methenamine, sodium salicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4404 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) 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 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:0363-4404-24 1 in 1 CARTON 02/22/2017 1 24 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 02/22/2017 Labeler - Walgreen Company (008965063) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Reese Pharmaceutical Co 004172052 repack(0363-4404) , relabel(0363-4404) Establishment Name Address ID/FEI Business Operations Pharbest 557054835 manufacture(0363-4404)