NDC 21695-890 Belladonna Alkaloids With Phenobartbital

NDC Product Code 21695-890

NDC CODE: 21695-890

Proprietary Name: Belladonna Alkaloids With Phenobartbital What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
WEST;WARD;140
Score: 2

NDC Code Structure

  • 21695 - Rebel Distributors Corp
    • 21695-890 - Belladonna Alkaloids With Phenobartbital

NDC 21695-890-30

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

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

NDC Product Information

Belladonna Alkaloids With Phenobartbital with NDC 21695-890 is a product labeled by Rebel Distributors Corp. The generic name of Belladonna Alkaloids With Phenobartbital is . The product's dosage form is and is administered via form.

Labeler Name: Rebel Distributors Corp

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.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CALCIUM STEARATE (UNII: 776XM7047L)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Labeler Information

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

Labeler Name: Rebel Distributors Corp
Labeler Code: 21695
Start Marketing Date: 08-31-2004 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: 12-31-2017 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 - INACTIVATED, the listing data was inactivated by the FDA. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Belladonna Alkaloid Combinations and Phenobarbital

Belladonna Alkaloid Combinations and Phenobarbital is pronounced as (bell a don' a) (fee noe bar' bi tal)

Why is belladonna alkaloid combinations and phenobarbital medication prescribed?
Belladonna alkaloid combinations and phenobarbital are used to relieve cramping pains in conditions such as irritable bowel syndrome and spastic colon. They also are used...
[Read More]

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Belladonna Alkaloids With Phenobartbital Product Label Images

Belladonna Alkaloids With Phenobartbital 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

Description:

Each Tablet contains:            Atropine Sulfate, USP..........................0.0194 mg            Hyoscyamine Sulfate, USP.................0.1037 mg            Scopolamine Hydrobromide, USP.....0.0065 mg            Phenobarbital, USP..................................16.2 mgInactive ingredients: Anhydrous Lactose, Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, and Microcrystalline Cellulose.

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.

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 following indications as “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. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

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 magacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis.Belladonna alkaloids with phenobarbital 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.

Warnings:

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.Belladonna alkaloids with phenobarbital 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.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.

Precautions:

Use 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.Theoretically, with overdosage, a curare-like action may occur.

Carcinogenesis, Mutagenesis.

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy Category C.

Animal reproduction studies have not been conducted with belladonna alkaloids with phenobarbital tablets. It is not known whether belladonna alkaloids with phenobarbital tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Belladonna alkaloids with phenobarbital tablets should be given to a pregnant woman only if clearly needed.

Nursing Mothers.

It is not know whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when belladonna alkaloids with phenobarbital tablets are administered to a nursing mother.

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. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

Dosage And Administration:

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

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, 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 added.

How Supplied:

Belladonna Alkaloids with Phenobarbital Tablets are supplied as; White, round, scored, compressed tablets imprinted “West-ward 140”.Bottles of 30NDC 21695-890-30 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.

Other

Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised April 2005Repackaged by:Rebel Distributors Corp Thousand Oaks, CA 91320

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