Phenohytro
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Winder Laboratories, Llc
Human Prescription Drug
NDC 75826-118Phenohytro also known as Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide is a human prescription drug labeled by 'Winder Laboratories, Llc'. National Drug Code (NDC) number for Phenohytro is 75826-118. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Phenohytro drug includes Atropine Sulfate - .0194 mg/1 Hyoscyamine Sulfate - .1037 mg/1 Phenobarbital - 16.2 mg/1 Scopolamine Hydrobromide - .0065 mg/1 . The currest status of Phenohytro drug is Active.
Drug Information:
| Drug NDC: | 75826-118 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Phenohytro |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Winder Laboratories, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ATROPINE SULFATE - .0194 mg/1
HYOSCYAMINE SULFATE - .1037 mg/1
PHENOBARBITAL - 16.2 mg/1
SCOPOLAMINE HYDROBROMIDE - .0065 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 29 Feb, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Winder Laboratories, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1046815
1739887
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0375826118100
|
| UPC stands for Universal Product Code. |
| UNII: | 03J5ZE7KA5
F2R8V82B84
YQE403BP4D
451IFR0GXB
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Anticholinergic [EPC]
Cholinergic Antagonists [MoA]
Cholinergic Muscarinic Antagonist [EPC]
Cholinergic Muscarinic Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
| DEA Schedule: | CIV |
| This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 75826-118-00 | 1000 TABLET in 1 BOTTLE, PLASTIC (75826-118-00) | 29 Feb, 2016 | N/A | No |
| 75826-118-10 | 100 TABLET in 1 BOTTLE, PLASTIC (75826-118-10) | 29 Feb, 2016 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Phenohytro phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide anhydrous lactose calcium stearate silicon dioxide starch, corn cellulose, microcrystalline phenobarbital phenobarbital hyoscyamine sulfate hyoscyamine atropine sulfate atropine scopolamine hydrobromide scopolamine 112
Indications and Usage:
Indications and usage based on a review of this drug by the national academy of sciencesânational research council and/or other information, fda has classified the indications as follows: âpossiblyâ effective: for use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. may also be useful as adjunctive therapy in the treatment of duodenal ulcer. final classification of the less-than-effective indications requires further investigation. it has not been shown conclusively whether anticholinergic/antispasmodic drugs aid in the healing of a duodenal ulcer, decrease the rate of recurrences or prevent complications.
Warnings:
Warnings phenohytro⢠tablets can cause fetal harm when administered to a pregnant woman. animal reproduction studies have not been conducted with phenohytroâ¢. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. in the presence of a high environmental temperature, heat prostration (fever and heatstroke due to decreased sweating) can occur with belladonna alkaloids. diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. administration of phenohytro⢠tablets to a patient exhibiting diarrhea would be inappropriate and possibly harmful. phenohytro⢠tablets may produce drowsiness or blurred vision. should these occur, the patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work. phe
Read more...nobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. when the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs. since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.
General Precautions:
General phenohytro⢠tablets should be used with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension. belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. phenohytro⢠tablets should not be used in the presence of complication of biliary tract disease. in the event of overdosage of phenohytro⢠tablets, a curare-like action may occur.
Dosage and Administration:
Dosage and administration the dosage of phenohytro⢠should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects. phenohytro⢠tablets - adults: one or two phenohytro⢠tablets three or four times a day according to condition and severity of symptoms.
Contraindications:
Contraindications phenohytro⢠tablets are contraindicated in patients with glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis. phenohytro⢠tablets are contraindicated in patients with known hypersensitivity to any of the ingredients. phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement.
Adverse Reactions:
Adverse reactions adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema and similar conditions. hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. rarely, exfoliative dermatitis (e.g. stevens-johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. the
Read more... skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. in a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital. phenobarbital may produce excitement in some patients, rather than a sedative effect. in patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions. to report suspected adverse reactions, contact winder laboratories, llc at 1-770-307-0702 or the fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Use in Specific Population:
Use in special patient populations pregnancy pregnancy category d animal reproduction studies have not been conducted with phenohytroâ¢. there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (see warnings ). nursing mothers it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when phenohytro⢠tablets are administered to a nursing woman. geriatric use elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.
Use in Pregnancy:
Pregnancy pregnancy category d animal reproduction studies have not been conducted with phenohytroâ¢. there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (see warnings ).
Geriatric Use:
Geriatric use elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.
Overdosage:
Overdosage the signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and cns stimulation. treatment should consist of gastric lavage, emetics, and activated charcoal. if indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be used.
Description:
Description each phenohytro⢠tablet contains: phenobarbital, usp..................................... 16.2 mg hyoscyamine sulfate, usp...................... 0.1037 mg atropine sulfate, usp .............................0.0194 mg scopolamine hydrobromide, usp ...........0.0065 mg inactive ingredients: anhydrous lactose, calcium stearate, colloidal silicon dioxide, corn starch, and microcrystalline cellulose.
Clinical Pharmacology:
Clinical pharmacology phenohytro⢠tablets combine natural belladonna alkaloids in a specific, fixed ratio with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals have not been performed to evaluate carcinogenic potential of phenohytro⢠tablets.
How Supplied:
How supplied / storage and handling phenohytro⢠tablets are supplied as: white, round tablets debossed â112â on one side and plain on the other side. bottles of 100 tablets, ndc 75826-118-10 bottles of 1000 tablets, ndc 75826-118-00 store at 20°-25°c (68°-77°f) [see usp controlled room temperature]. protect from light and moisture. dispense in a tight, light-resistant container as defined in the usp using a child-resistant closure. use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser. manufactured by: winder laboratories, llc winder, ga 30680 www.phenohytro.com rev. 03/16
Package Label Principal Display Panel:
Phenohytro⢠- 100 tablets rev. 07/19