Label: METHENAMINE AND SODIUM SALICYLATE (NSAID)- methenamine, sodium salicylate tablet
- NDC Code(s): 70985-030-11, 70985-030-13
- Packager: Drug Ocean LLC
- 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 March 27, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- 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 behavior 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
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients: benzoic acid, cellulose, croscarmellose sodium, edible black ink, fd & c red #40 lake, fd & c yellow #6 lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, silica, stearic acid, titanium dioxide, triethyl citrate
- Questions or comments? Call 1-844-200-6566
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PRINCIPAL DISPLAY PANEL
Carton Label
DRUG OCEAN NDC 70985- 030-11
Methenamine and Sodium Salicylate (NSAID) Tablets 162 mg; 162.5 mg
Antibacterial Urinary Pain Relief
- Helps Control the Infection*
- Plus General Pain Reliever
* Helps inhibit the progression of infection until you see your healthcare professional. This product is not intended to replace medical care.
18 Tablets
Blister Label
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PRINCIPAL DISPLAY PANEL
Carton Label
DRUG OCEAN NDC 70985- 030-13
Methenamine and Sodium Salicylate (NSAID) Tablets 162 mg; 162.5 mg
Antibacterial Urinary Pain Relief
- Helps Control the Infection*
- Plus General Pain Reliever
* Helps inhibit the progression of infection until you see your healthcare professional. This product is not intended to replace medical care.
24 Tablets
Blister Label
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INGREDIENTS AND APPEARANCE
METHENAMINE AND SODIUM SALICYLATE (NSAID)
methenamine, sodium salicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70985-030 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) POWDERED CELLULOSE (UNII: SMD1X3XO9M) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color red Score no score Shape ROUND Size 10mm Flavor Imprint Code URO Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70985-030-11 1 in 1 BOX 03/12/2024 1 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:70985-030-13 1 in 1 BOX 03/12/2024 2 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 03/12/2024 Labeler - Drug Ocean LLC (080381835)