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Methenamine and Sodium Salicylate

Dosage form: tablet
Ingredients: METHENAMINE 162mg, SODIUM SALICYLATE 162.5mg
Labeler: AMOL PHARMACEUTICALS PRIVATE LIMITED
NDC code: 63189-005

Methenamine and Sodium Salicylate (Tablets)

Drug Facts

Active Ingredients (in each tablet):

Methenamine 162 mg

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

Purpose

Antibacterial

Analgesic (pain reliever)

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

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 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.

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

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.

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.

  • HELPS CONTROL THE INFECTION*
  • PLUS GENERAL PAIN RELIEVER

Antibacterial Urinary Pain Relief

Methenamine and Sodium Salicylate (NSAID)

Packaging

METHENAMINE AND SODIUM SALICYLATE 
methenamine, sodium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63189-005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHENAMINE (METHENAMINE) METHENAMINE162 mg
SODIUM SALICYLATE (SALICYLIC ACID) SODIUM SALICYLATE162.5 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
MAGNESIUM STEARATE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
Colorred (Reddish Orange) Scoreno score
ShapeROUNDSize11mm
FlavorImprint CodeAZO;UD
Contains    
Packaging
#Item CodePackage Description
1NDC:63189-005-021 POUCH in 1 CARTON
12 TABLET in 1 POUCH
2NDC:63189-005-061 POUCH in 1 CARTON
26 TABLET in 1 POUCH
3NDC:63189-005-201 BLISTER PACK in 1 CARTON
320 TABLET in 1 BLISTER PACK
4NDC:63189-005-241 BLISTER PACK in 1 CARTON
424 TABLET in 1 BLISTER PACK
5NDC:63189-005-301 PACKAGE in 1 CARTON
530 TABLET in 1 PACKAGE
6NDC:63189-005-601 BOTTLE in 1 CARTON
660 TABLET in 1 BOTTLE
7NDC:63189-005-041 POUCH in 1 CARTON
74 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/03/2015
Labeler - AMOL PHARMACEUTICALS PRIVATE LIMITED (676245969)
Establishment
NameAddressID/FEIOperations
AMOL PHARMACEUTICALS PRIVATE LIMITED676245969manufacture(63189-005)

Revised: 11/2015
 
AMOL PHARMACEUTICALS PRIVATE LIMITED

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.