Label: CVS DUAL ACTION PAIN RELIEF- methenamine, sodium salicylate tablet
- NDC Code(s): 51316-777-48
- Packager: CVS Pharmacy, Inc
- Category: HUMAN OTC DRUG LABEL
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 December 18, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
CVS DUAL ACTION PAIN RELIEF
methenamine, sodium salicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-777 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:51316-777-48 2 in 1 CARTON 12/18/2024 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 10/16/2024 Labeler - CVS Pharmacy, Inc (062312574) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Pharbest 557054835 manufacture(51316-777)