Uribel

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Methenamine and methylene blue work as mild antiseptics that fight bacteria in the urine and bladder.

Phenyl salicylate is a mild pain reliever.

Sodium biphosphate is a form of phosphorus, which is a naturally occurring substance that is important in every cell in the body.

Hyoscyamine, methenamine, methylene blue, phenyl salicylate, sodium biphosphate is a combination medicine used to treat bladder irritation (pain, spasms, inflammation) caused by urinary tract infection. This medicine is also used to prevent bladder discomfort during a medical procedure.

Hyoscyamine, methenamine, methylene blue, phenyl salicylate, sodium biphosphate may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe dizziness, blurred vision, fast heart rate;

• painful or difficult urination; or

• shortness of breath.

Older adults may be more likely to have side effects from this medication.

Methylene blue will most likely cause your urine or stools to appear blue or green in color. This is a normal side effect of the medication and will not cause any harm.

Common side effects may include:

• dizziness, drowsiness;

• dry mouth; or

• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Urelle® in children. However, use is not recommended in children 6 years of age and younger.

Geriatric

No information is available on the relationship of age to the effects of Urelle® in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acetazolamide
• Amifampridine
• Amisulpride
• Amitriptyline
• Amoxapine
• Amphetamine
• Benzphetamine
• Bepridil
• Bupropion
• Carbamazepine
• Carbidopa
• Carbinoxamine
• Cisapride
• Citalopram
• Clomipramine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Deutetrabenazine
• Dextroamphetamine
• Doxepin
• Doxylamine
• Dronedarone
• Duloxetine
• Entacapone
• Escitalopram
• Fluoxetine
• Fluvoxamine
• Hydroxytryptophan
• Imipramine
• Isocarboxazid
• Levodopa
• Levomilnacipran
• Linezolid
• Lisdexamfetamine
• Mafenide
• Maprotiline
• Meperidine
• Mesoridazine
• Methamphetamine
• Milnacipran
• Mirtazapine
• Nortriptyline
• Opicapone
• Paroxetine
• Phenelzine
• Phentermine
• Pimozide
• Piperaquine
• Potassium
• Protriptyline
• Pseudoephedrine
• Rizatriptan
• Safinamide
• Saquinavir
• Selegiline
• Sertraline
• Silver Sulfadiazine
• Sparfloxacin
• Sulfabenzamide
• Sulfacetamide
• Sulfacytine
• Sulfadiazine
• Sulfamerazine
• Sulfamethazine
• Sulfamethoxazole
• Sulfanilamide
• Sulfapyridine
• Sulfasalazine
• Sulfathiazole
• Sulfisoxazole
• Sumatriptan
• Tapentadol
• Terfenadine
• Thioridazine
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Ziprasidone
• Zolmitriptan
• Zonisamide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Alfentanil
• Alfuzosin
• Almotriptan
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atropine
• Azithromycin
• Bedaquiline
• Bromazepam
• Bromfenac
• Brompheniramine
• Bufexamac
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Butorphanol
• Celecoxib
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clonixin
• Clozapine
• Cocaine
• Crizotinib
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexibuprofen
• Dexketoprofen
• Dextromethorphan
• Dibenzepin
• Diclofenac
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Droxicam
• Efavirenz
• Eletriptan
• Erythromycin
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fingolimod
• Flecainide
• Flibanserin
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Foscarnet
• Frovatriptan
• Furazolidone
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroxychloroquine
• Hydroxyzine
• Ibuprofen
• Ibutilide
• Iloperidone
• Imipramine
• Indomethacin
• Iobenguane I 123
• Iproniazid
• Ivabradine
• Ketoconazole
• Ketoprofen
• Lapatinib
• Leuprolide
• Levofloxacin
• Levorphanol
• Lithium
• Lofepramine
• Lopinavir
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Melitracen
• Meloxicam
• Methadone
• Metronidazole
• Midodrine
• Mifepristone
• Moclobemide
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nabumetone
• Nafarelin
• Nalbuphine
• Naproxen
• Naratriptan
• Nefazodone
• Nepafenac
• Nialamide
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ondansetron
• Opipramol
• Oxaprozin
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Oxyphenbutazone
• Paliperidone
• Palonosetron
• Panobinostat
• Parecoxib
• Pasireotide
• Pazopanib
• Pentazocine
• Periciazine
• Phenylbutazone
• Piketoprofen
• Pimavanserin
• Piroxicam
• Pitolisant
• Posaconazole
• Procainamide
• Procarbazine
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propyphenazone
• Proquazone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Rasagiline
• Remifentanil
• Ribociclib
• Rofecoxib
• Salmeterol
• Sevoflurane
• Sibutramine
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulindac
• Sulpiride
• Sunitinib
• Tacrolimus
• Telavancin
• Telithromycin
• Tenoxicam
• Tetrabenazine
• Tianeptine
• Tiaprofenic Acid
• Tiotropium
• Tizanidine
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Trimipramine
• Triptorelin
• Valbenazine
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Vinflunine
• Voriconazole
• Ziprasidone
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Calcium Acetate
• Calcium Carbonate
• Calcium Citrate
• Chlorpropamide
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Metformin
• Nateglinide
• Repaglinide
• Tolazamide
• Tolbutamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or
• Coronary heart disease or
• Glaucoma or
• Heart disease (e.g., mitral stenosis) or
• Heart rhythm problems (e.g., arrhythmia) or
• Myasthenia gravis (severe muscle weakness) or
• Stomach or intestinal (bowel) blockage or
• Stomach ulcers or
• Urinary problems (e.g., bladder blockage due to an enlarged prostate)—Use with caution. May make these conditions worse.

• Allergy or intolerance to belladonna or salicylates—Use with caution. May be sensitive to this medicine also.

This section provides information on the proper use of a number of products that contain hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It may not be specific to Uribel. Please read with care.

Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.

Drink extra fluids after you take this medicine so you will pass more urine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of symptoms of urinary tract infection or diagnostic procedure:
    • Adults—One tablet four times a day
    • Children 7 years of age and older—Use and dose must be determined by your doctor.
    • Children 6 years of age and younger—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Uribel for longer than you were told by your doctor.
• This medicine may prevent other drugs taken by mouth from getting into the body. If you take other drugs by mouth, you may need to take them at some other time than this medicine. Talk with your doctor.
• Use with care in children. Talk with the doctor.
• If Uribel is taken by accident, get medical help right away.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Uribel while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Uribel ™ capsules for oral administration

HYOSCYAMINE SULFATE. [620-61-1] [3(S)- endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether.

METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform.

METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol.

SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5.

Uribel ™ capsules contain inactive ingredients: Dicalcium Phosphate, FD&C Blue #1, FD&C Red #3, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Propylene Glycol, Shellac, Silicon Dioxide, Sodium Hydroxide, Stearic Acid, and Titanium Dioxide.

Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue use immediately.

Cross sensitivity and/or related problems

patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.

Pregnancy/Reproduction (FDA Pregnancy Category C)

hyoscyamine and methenamine cross the placenta. Studies concerning the effect of hyoscyamine and methenamine on pregnancy and reproduction have not been done in animals or humans. Thus it is not known whether Uribel ™ capsules cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Uribel ™ capsules should be given to a pregnant woman only if clearly needed.

Breast feeding

problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk. Accordingly, Uribel ™ capsules should be given to a nursing mother with caution and only if clearly needed.

Prolonged use

there have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.

Pediatric

infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

Geriatric Use

use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness or confusion.

NDC 0076-0111-01

Uribel ™

EACH CAPSULE CONTAINS

Methenamine 118 mg

Sodium Phosphate Monobasic 40.8 mg

Phenyl Salicylate 36 mg

Methylene Blue 10 mg

Hyoscyamine Sulfate 0.12 mg

Rx ONLY

100 Capsules

Uribel ™ is a trademark of Star Pharmaceuticals, LLC

Distributed by:

MISSION PHARMACAL COMPANY

San Antonio, TX 78230

Manufactured for:

STAR PHARMACEUTICALS, LLC

Ft. Lauderdale, FL33306