HOW SUPPLIED SECTION.

HOW SUPPLIED. RE-PB Hyos Elixir is 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 ACCIDENTALOVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT POISON CONTROL CENTER IMMEDIATELY.Manufactured by:Great Southern LaboratoriesHouston, TX 77099-3405Manufactured for:Rivers Edge Pharmaceuticals, LLCSuwanee, GA 30024Repackaged by: Rebel Distributors CorpThousand Oaks, CA 91320.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. RE-PB Hyos Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital iscontraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital producesrestlessness and/or exctextent.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.

DESCRIPTION SECTION.

DESCRIPTION. Each mL (teaspoonful) of elixir contains: Phenobarbital, USP ............................................. 16.2 mg(WARNING: may be habit forming)Hyoscyamine Sulfate, USP .............................. 0.1037 mgAtropine Sulfate, USP ..................................... 0.0194 mgScopolamine Hydrobromide, USP ................... 0.0065 mgAlcohol not more than 23.8% INACTIVE INGREDIENTS: Artificial Grape Flavor, Ethyl Alcohol, FD and Blue 1, FD and Red 40, Glycerin, Purified Water USP, Sodium Saccharin,Sorbitol Solution 70%, and Sucrose.

DOSAGE & ADMINISTRATION SECTION.

The dosage of RE-PB Hyos Elixir should be adjusted to the needs of the individual patient to assuresymptomatic control with minimum of adverse effects.Adults: One or two teaspoonfuls of elixir three or four times day according to conditions and severity of symptoms.Pediatric patients: may be dosed every to hours.Starting DosageBody Weightq4hq6h10 lb. (4.5 kg) 0.5 mL 0.75 mL 20 lb. (9.1 kg) 1.0 mL 1.5 mL 30 lb. (13.6 kg) 1.5 mL 2.0 mL 50 lb. (22.7 kg) 1/2 tsp 3/4 tsp 75 lb. (34 kg) 3/4 tsp tsp 100 lb. (45.4kg) tsp 1/2 tsp.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Adverse reactions associated with anticholinergics and/or anticonvulsants are: dry mouth; tachycardia; urinaryhesitancy and retention; palpitation; blurred vision; prolonged pupil dilation; cycloplegia; increased ocular tension; loss oftaste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; severe allergicreaction 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 reactwith symptoms of exctextent, agitation and drowsiness to even small doses of the drug. Phenobarbital may produceexctextent in some patients, rather than sedative effect. In patients habituated to barbiturates, abrupt withdrawal mayproduce 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.

INDICATIONS & USAGE SECTION.

INDICATION AND USAGE. FDA has classified the following indications as possibly effective: For use as adjunctive therapy in the treatment ofirritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful asadjunctive therapy in the treatment of duodenal ulcer.IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ ANTISPASMODIC DRUGS AID IN THEHEALING OF DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

OVERDOSAGE SECTION.

OVERDOSAGE. The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot anddry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Call your doctor orlocal Poison Control Center if overdosage is suspected.

PRECAUTIONS SECTION.

PRECAUTIONS. GENERAL:Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heartdisease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension. Belladonna alkaloids may produce delay in gastric emptying (antral stasis) which would complicate the management ofgastric ulcer. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically,with overdosage, 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 Elixircan cause fetal harm when administered to pregnant woman or can affect reproduction capacity. RE-PB Hyos Elixirshould be given to 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, cautionshould be exercised when RE-PB Hyos Elixir is administered to nursing woman.

WARNINGS SECTION.

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 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 history of physical and/or psychological drug dependence.Barbiturates should be used with caution in patients with hepatic dysfunction.