Phenobarbital With Belladonna Alkaloids

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide

Bryant Ranch Prepack
Human Prescription Drug
NDC 63629-2050

Phenobarbital With Belladonna Alkaloids also known as Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide is a human prescription drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Phenobarbital With Belladonna Alkaloids is 63629-2050. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Phenobarbital With Belladonna Alkaloids 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 Phenobarbital With Belladonna Alkaloids drug is Active.

Drug Information:

Drug NDC:	63629-2050
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:	Phenobarbital With Belladonna Alkaloids
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:	Bryant Ranch Prepack
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:	11 Apr, 2020
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:	Bryant Ranch Prepack
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1046815
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.
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
63629-2050-1	100 TABLET in 1 BOTTLE (63629-2050-1)	08 Mar, 2022	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.

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Phenobarbital With Belladonna Alkaloids

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide

Tablet
Bryant Ranch Prepack
NDC: 63629-2050

Product Elements:

Phenobarbital with belladonna alkaloids phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide phenobarbital phenobarbital hyoscyamine sulfate hyoscyamine atropine sulfate atropine scopolamine hydrobromide scopolamine calcium stearate silicon dioxide lactose, unspecified form microcrystalline cellulose starch, corn pba;7

Drug Interactions:

Drug interactions phenobarbital 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.

Indications and Usage:

Indications and usage based on a review of this drug by the national academy of sciences-national research council and/or other information, fda has classified the indications as follows: "possibly" 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 phenobarbital with belladonna alkaloids tablets can cause fetal harm when administered to a pregnant woman. animal reproduction studies have not been conducted with phenobarbital with belladonna alkaloids tablets. 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 can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating). diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. in this instance, treatment with this drug would be inappropriate and possibly harmful. phenobarbital with belladonna alkaloids tablets may produce drowsiness or blurred vision. the patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other mach Read more...

inery, and not to perform hazardous work. phenobarbital 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 use with caution in patients with: autonomic neuropathy hepatic or renal disease hyperthyroidism coronary heart disease congestive heart failure cardiac arrhythmias tachycardia hypertension belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. do not rely on the use of the drug in the presence of complication of biliary tract disease. theoretically, with overdosage, a curare-like action may occur.

Dosage and Administration:

Dosage and administration the dosage of phenobarbital with belladonna alkaloids tablets should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects. phenobarbital with belladonna alkaloids tablets - adults: one or two phenobarbital with belladonna alkaloids tablets three or four times a day according to condition and severity of symptoms.

Contraindications:

Contraindications 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; 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. t Read more...

he 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. to report suspected adverse reactions, contact apothecon florida, llc at 1-888-514-4727 or the fda at 1-800-fda-1088 or www.fda.gov/medwatch .

Drug Interactions:

Use in Pregnancy:

Pregnancy animal reproduction studies have not been conducted with phenobarbital with belladonna alkaloids tablets. 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.

dependence:

Dependence in patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

Description:

Description each phenobarbital with belladonna alkaloids 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

Clinical Pharmacology:

Clinical pharmacology this drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined 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.

How Supplied:

How supplied phenobarbital with belladonna alkaloids tablets are supplied as: white, round, convex tablet debossed with 'pba' on one side and '7' on the other side. bottles of 100 tablets - ndc 63629-2050-1 store at 20Â°-25Â°c (68Â°-77Â°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. dea exempt product

Information for Patients:

Information for patients phenobarbital with belladonna alkaloids tablets may produce drowsiness or blurred vision. the patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.

Package Label Principal Display Panel:

Phenobarbital w/belladonna alkaloids #100 label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.