RE-PB HYOS ELIXIR- belladonna alkaloids w/ phenobarbital elixir

RE-PB HYOS ELIXIR by

Drug Labeling and Warnings

RE-PB HYOS ELIXIR by is a Prescription medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

DOSAGE & ADMINISTRATION

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 Weight	q4h	q6h
10 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	1 tsp
100 lb. (45.4kg)	1 tsp	1 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

Principal Display Panel

INGREDIENTS AND APPEARANCE

RE-PB HYOS ELIXIR 
belladonna alkaloids w/ phenobarbital elixir

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 21695-594(NDC: 68032-395)
Route of Administration	ORAL	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D)	PHENOBARBITAL	16.2 mg  in 5 mL
HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)	HYOSCYAMINE SULFATE	0.1037 mg  in 5 mL
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	ATROPINE SULFATE	0.0194 mg  in 5 mL
SCOPOLAMINE HYDROBROMIDE (UNII: 451IFR0GXB) (SCOPOLAMINE - UNII:DL48G20X8X)	SCOPOLAMINE HYDROBROMIDE	0.0065 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-594-16	480 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		10/20/2009

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK