METHENAMINE AND SODIUM SALICYLATE (NSAID)- methenamine, sodium salicylate tablet 
Drug Ocean LLC

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.

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METHENAMINE AND SODIUM SALICYLATE (NSAID) TABLETS

Drug Facts

Active ingredient (in each tablet)

Methenamine 162 mg

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

Purpose

Antibacterial

Analgesic (pain reliever)

Uses

Temporarily relieves:

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:

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 breastfeeding, ask a health professional before use.

Keep out of reach of children.In case of an overdose, get medical help or contact a Poison Control Center right away.

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 Information:

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

Carton Label

DRUG OCEAN NDC 70985- 030-11

Methenamine and Sodium Salicylate (NSAID) Tablets 162 mg; 162.5 mg

Antibacterial Urinary Pain Relief

* Helps inhibit the progression of infection until you see your healthcare professional. This product is not intended to replace medical care.

18 Tablets

Container 18 tablets

Blister Label

Blister 18 Tablets

Carton Label

DRUG OCEAN NDC 70985- 030-13

Methenamine and Sodium Salicylate (NSAID) Tablets 162 mg; 162.5 mg

Antibacterial Urinary Pain Relief

* Helps inhibit the progression of infection until you see your healthcare professional. This product is not intended to replace medical care.

24 Tablets

container 24 tablets

Blister Label

blister 24 tablets

METHENAMINE AND SODIUM SALICYLATE  (NSAID)
methenamine, sodium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70985-030
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE162 mg
SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE162.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code URO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70985-030-111 in 1 BOX03/12/2024
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70985-030-131 in 1 BOX03/12/2024
224 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/12/2024
Labeler - Drug Ocean LLC (080381835)

Revised: 3/2024
Document Id: 14a56005-2638-072e-e063-6294a90a87dd
Set id: 9a0766dd-3403-471b-8377-ae76b4b6b5a5
Version: 2
Effective Time: 20240327
 
Drug Ocean LLC