NDC 0076-0901 Hyophen

NDC Product Code 0076-0901

NDC 0076-0901-01

Package Description: 100 TABLET in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Hyophen with NDC 0076-0901 is a product labeled by Star Pharmaceuticals, Llc. The generic name of Hyophen is . The product's dosage form is and is administered via form.

Labeler Name: Star Pharmaceuticals, Llc

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CROSPOVIDONE (UNII: 2S7830E561)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • STARCH, RICE (UNII: 4DGK8B7I3S)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Star Pharmaceuticals, Llc
Labeler Code: 0076
Start Marketing Date: 09-21-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2018 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Hyoscyamine

Hyoscyamine is pronounced as (hye oh sye' a meen)

Why is hyoscyamine medication prescribed?
Hyoscyamine is used to control symptoms associated with disorders of the gastrointestinal (GI) tract. It works by decreasing the motion of the stomach and intestines and ...
[Read More]

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Hyophen Product Label Images

Hyophen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only100 Tablets

Rx OnlyHyophen™ is a registered trademark licensed to Star Pharmaceuticals, LLCDistributed by:

BIOCOMP PHARMA, INC.

San Antonio, Texas 78230
Manufactured for:

STELLAR PHARMACAL

Ft. Lauderdale, FL 07726
Rev. 90101-23 -07/12

NDC 0076-0901-01Rx OnlyHyophen™EACH TABLET CONTAINS


Methenamine 81.6 mg


Benzoic Acid 9.0 mg


Phenyl Salicylate 36.2 mg


Methylene Blue 10.8 mg


Hyoscyamine Sulfate 0.12 mg


100 TabletsHyophen™ is a registered trademark licensed to Star Pharmaceuticals. LLCDistributed by: BIOCOMP PHARMA, INC. San Antonio, Texas 78230Manufactured for: STELLAR PHARMACAL Ft. Lauderdale, FL 33306

Description

Hyophen


™ tablets for oral administration


Each tablet contains:Methenamine81.6 mgBenzoic Acid9.0 mgPhenyl Salicylate36.2 mgMethylene Blue10.8 mgHyoscyamine Sulfate0.12 mgHYOSCYAMINE 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; l-tropic acid ester with tropine; l-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 15.40%, 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


13ClN


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.


BENZOIC ACID. [65-85-0] Benzenecarboxylic acid; Benzeneformic acid; Benzenemethanoic acid. C


7H


6O


2; mol wt 122.12, C 68.85%, H 4.95%, O 26.20%. Exists as white powder or crystals, scales or needles. It has a strong odor and is slightly soluble in alcohol; also soluble in volatile and fixed oils, slightly soluble in petroleum ether.


Hyophen


™ tablets contain inactive ingredients: Crospovidone, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Rice Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc, and Titanium Dioxide.

Clinical Pharmacology

HYOSCYAMINE SULFATE is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout the body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Its biotransformation is hepatic. Its protein binding is moderate.METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70%-90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this at a pH of 5, approximately 20% is formaldehyde. Protein binding - some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at pH greater than 6.8.METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed by the gastrointestinal tract and rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged.PHENYL SALICYLATE releases salicylate, a mild analgesic for pain.BENZOIC ACID helps maintain an acid pH in the urine necessary for the degradation of methenamine.

Indications And Usage

Hyophen


™ tablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

Contraindications

Hypersensitivity to any of the ingredients is possible.Risk benefits should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis, acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Warnings

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

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

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


Hyophen


™ tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity and 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,


Hyophen


™ tablets 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.

Adverse Reactions

Cardiovascular: rapid heartbeat, flushingCentral Nervous System: blurred vision, dizziness, drowsinessGenitourinary: difficult micturition, acute urinary retentionGastrointestinal: dry mouth, nausea and vomitingRespiratory: shortness of breath or trouble breathingSerious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped.Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Stellar Pharmacal at 1-800-845-7827 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.

Drug Interactions

Because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce absorption of hyoscyamine, concurrent use with antacids may cause urine to become alkaline, reducing effectiveness of methenamine by inhibiting its conversion to formaldehyde). Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine; antimyasthenics (concurrent use with hyoscyamine may further reduce intestinal motility); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent use may intensify antimuscarinic side effects), opioid (narcotic analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria). Patients should be advised that the urine may become blue to blue-green and the feces may be discolored as a result of the excretion of the Methylene blue.

Drug Abuse And Dependence

A dependence on the use of


Hyophen


™ tablets has not been reported and due to the nature of its ingredients, abuse of


Hyophen


™ tablets is not expected.

Overdosage

Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms.Administration of small doses of diazepam to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary.If overdose is suspected, contact your local poison center or emergency room immediately. US residents can contact the US National Poison Hotline at 1-800-222-1222.

Dosage And Administration

Adults - one tablet orally 4 times per day followed by liberal fluid intake.


Older Children - Dosage must be individualized by physician. Not recommended for use in children six years of age or younger.

How Supplied

Hyophen


™ tablets are blue tablets imprinted with "SAT" on one side and "901" on opposite side. NDC 0076-0901-01, Bottle of 100 Tablets.

Storage

Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.Store at controlled room temperature 15°-30°C (59°-86°F).Keep in a cool, dry place.


Keep container tightly closed.


WARNING: Keep this and all drugs out of reach of children.

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