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  5. Label Information: Methenamine And Sodium Salicylate (nsaid)

FDA Label for Methenamine And Sodium Salicylate (nsaid)

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. PREGNANCY
    11. DOSAGE & ADMINISTRATION
    12. OTHER SAFETY INFORMATION
    13. INACTIVE INGREDIENT
    14. QUESTIONS OR COMMENTS? CALL 1-844-200-6566
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Methenamine And Sodium Salicylate (nsaid) Product Label

The following document was submitted to the FDA by the labeler of this product Drug Ocean Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active ingredient (in each tablet)

Methenamine 162 mg

Sodium Salicylate 162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug)


Otc - Purpose



Purpose

Antibacterial

Analgesic (pain reliever)


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 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 

Otc - Do Not Use



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

Otc - Ask 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

Otc - Ask Doctor/Pharmacist



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 

Otc - When Using



When using this product:do not take more than the recommended dosage


Otc - Stop Use



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

Pregnancy



If pregnant or breastfeeding, 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


Other Safety Information



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

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



Distributed by:

Drug Ocean LLC
1 Bridge Plaza, North Central Road,
6th Floor, Suite 675,
Fort Lee, NJ 07024


Made in India


Mfg License Code:
RA/Drug/RAJ.-1750

ORG 03/2024


Package Label.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

    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


* Please review the disclaimer below.