Phenohytro .0194 mg/1

PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE · TABLET · Winder Laboratories, LLC

No Recall HistoryCurrently in Shortage

Plain English

Phenohytro is a tablet containing phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide at .0194 mg/1, taken oral. Manufactured by Winder Laboratories, LLC.

Key Facts

Brand Name: Phenohytro
Generic Name: PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
NDC Code (Product): 75826-118
Manufacturer: Winder Laboratories, LLC
Strength: .0194 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
DEA Schedule: Schedule IV (Controlled)
Marketing Start: 02/29/2016

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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.

Dosage & 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.

Warnings

WARNINGS Phenohytro™ Tablets can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Phenohytro™. 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. 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. …

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 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 c…

Frequently Asked Questions

What is Phenohytro used for?

Phenohytro contains PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE. It is a tablet taken oral. Consult your doctor for specific uses.

Is Phenohytro a controlled substance?

Yes, Phenohytro is classified as CIV under the DEA Controlled Substances Act.

What is the generic name for Phenohytro?

The generic name for Phenohytro is PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE. There are 6 other brand versions of PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE.

What is the NDC code for Phenohytro .0194 mg/1?

The NDC (National Drug Code) for Phenohytro .0194 mg/1 is 75826-118, listed by Winder Laboratories, LLC.

Product NDC

75826-118

Package NDC

75826-118-00

Other Phenobarbital, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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