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Re-pb Hyos Elixir (Donnatal, Phenohytro) Package Insert

Status:
Prescription (Rx) Controlled substance Schedule IV Facts
Strength:
16.2 mg/5 mL, 0.1037 mg/5 mL, 0.0194 mg/5 mL, 0.0065 mg/5 mL
Brand names:
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Re-pb Hyos Elixir

DESCRIPTION

Each 5 mL (teaspoonful) of elixir contains:

Phenobarbital, USP ............................................. 16.2 mg

(WARNING: may be habit forming)

Hyoscyamine Sulfate, USP .............................. 0.1037 mg

Atropine Sulfate, USP ..................................... 0.0194 mg

Scopolamine Hydrobromide, USP ................... 0.0065 mg

Alcohol not more than 23.8%

INACTIVE INGREDIENTS:

Artificial Grape Flavor, Ethyl Alcohol, FD and C Blue #1, FD and C Red #40, Glycerin, Purified Water USP, Sodium Saccharin,

Sorbitol Solution 70%, and Sucrose.

CLINICAL PHARMACOLOGY

This drug combination provides peripheral anticholinergic/antispasmodic action and mild sedation.

INDICATION AND USAGE

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 A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

CONTRAINDICATIONS

RE-PB Hyos Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is

contraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital produces

restlessness and/or excitement.

It is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis;

intestinal atony; unstable cardiovascular status in acute hemorrhage; hiatal hernia associated with reflux esophagitis;

obstructive disease of the gastrointestinal tract; or severe ulcerative colitis

WARNINGS

Heat prostration can occur with belladonna alkaloids in high temperatures.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.

In this instance, treatment with this drug could be harmful.

RE-PB Hyos Elixir may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery. Phenobarbital may decrease the effect of anticoagulants, and larger doses of the anticoagulant may be needed for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to patients who are susceptible to addiction or to those with a history of physical and/or psychological drug dependence.

Barbiturates should be used with caution in patients with hepatic dysfunction.

PRECAUTIONS

GENERAL:

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. 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.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:

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

PREGNANCY CATEGORY C:

Animal reproduction studies have not been conducted with RE-PB Hyos Elixir. It is not known whether RE-PB Hyos Elixir

can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RE-PB Hyos Elixir

should be given to a pregnant woman only if clearly needed.

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 RE-PB Hyos Elixir is administered to a nursing woman.

ADVERSE REACTIONS

Adverse reactions associated with anticholinergics and/or anticonvulsants are: dry mouth; tachycardia; urinary

hesitancy and retention; palpitation; blurred vision; prolonged pupil dilation; cycloplegia; increased ocular tension; loss of

taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; severe allergic

reaction or drug idiosyncrasies, including anaphylaxis, hives and/or other dermal manifestations; decreased sweating; impotence; suppression of lactation; constipation; bloated feeling and musculoskeletal pain. Elderly patients may react

with symptoms of excitement, agitation and drowsiness 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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. Call your doctor or

local Poison Control Center if overdosage is suspected.

The dosage of RE-PB Hyos Elixir should be adjusted to the needs of the individual patient to assure

symptomatic control with a minimum of adverse effects.

Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.

Pediatric patients: may be dosed every 4 to 6 hours.

Starting Dosage

Body Weightq4hq6h
10 lb. (4.5 kg)0.5 mL0.75 mL
20 lb. (9.1 kg)1.0 mL1.5 mL
30 lb. (13.6 kg)1.5 mL2.0 mL
50 lb. (22.7 kg)1/2 tsp3/4 tsp
75 lb. (34 kg)3/4 tsp1 tsp
100 lb. (45.4kg)1 tsp1 1/2 tsp

HOW SUPPLIED

RE-PB Hyos Elixir is a purple colored, grape flavored liquid.

NDC 21695-594-16 in bottles of 16 oz.

WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL

OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Manufactured by:

Great Southern Laboratories

Houston, TX 77099-3405

Manufactured for:

River’s Edge Pharmaceuticals, LLC

Suwanee, GA 30024

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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Drug information for Re-pb Hyos Elixir

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule IVSchedule IV: low potential for abuse relative to Schedule III.
Drug class Anticholinergic, Cholinergic Muscarinic Antagonist
Active ingredients Phenobarbital 16.2 mg/5 mL, Hyoscyamine sulfate 0.1037 mg/5 mL, Atropine sulfate 0.0194 mg/5 mL, Scopolamine hydrobromide 0.0065 mg/5 mL
Dosage form Elixir
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Rebel Distributors Corp
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Packages (NDC)
Package
16.2 mg/5 mL, 0.1037 mg/5 mL, 0.0194 mg/5 mL, 0.0065 mg/5 mL – 480 ml in 1 bottle NDC 21695-594-16

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.