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 COMPLICAT...
The dosage of Phenobarbital with Belladonna Alkaloids Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects. One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms. 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...
www.fda.gov/medwatchPHENOBARBITAL with BELLADONNA ALKALOIDS ELIXIR
Rx Only
Rev. 1/18
Each 5 mL (teaspoonful) of elixir contains:
Phenobarbital, USP ................................................... 16.2 mg
Hyoscyamine Sulfate, USP ................................... 0.1037 mg
Atropine Sulfate, USP ........................................... 0.0194 mg
Scopolamine Hydrobromide, USP ......................... 0.0065 mg
Ethyl Alcohol, Purified Water, Glycerin, Methylparaben Sodium, Propylparaben Sodium, Saccharin Sodium, Xylitol, Citric Acid, Stevia Reb-A, Natural and Artificial Grape Flavor
This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.
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.
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.
Phenobarbital with Belladonna Alkaloids Elixir is 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.
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.
Phenobarbital with Belladonna Alkaloids Elixir 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.
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.
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Animal reproduction studies have not been conducted with Phenobarbital with Belladonna Alkaloids Elixir. It is not known whether Phenobarbital with Belladonna Alkaloids Elixir can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenobarbital with Belladonna Alkaloids Elixir should be given to a pregnant woman only if clearly needed.
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 Phenobarbital with Belladonna Alkaloids Elixir is administered to a nursing mother.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Lazarus Pharmaceuticals, Inc. at 1-888-296-9383 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The dosage of Phenobarbital with Belladonna Alkaloids Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
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
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.
NDC: 63629-2003-1: 120 mL Syrup in a BOTTLE
Pheno/Hyoscyamine Sul 16.2mg Elixir, #120
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71914-162-01 | ML - Milliliter | 71914-162 | 4fb35c46-4644-435f-9443-c4768e8b5663 | 1 | 2019-08-06 |
| 71914-162-04 | ML - Milliliter | 71914-162 | 9555bf51-b9ab-4a9d-bbaa-d66461a13516 | 1 | 2018-06-11 |
| 71914-162-10 | ML - Milliliter | 71914-162 | a7b71f0f-2e82-48ed-a72b-5474864244b6 | 1 | 2019-08-06 |
| 71914-162-16 | ML - Milliliter | 71914-162 | 953bbdb9-326b-4369-a4ee-bf0a83eab4c3 | 1 | 2018-06-11 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63629-2003 | 63629-2003-1 |
| 71914-162 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENOBARBITAL | YQE403BP4D | ACTIB |
| HYOSCYAMINE SULFATE | F2R8V82B84 | ACTIB |
| ATROPINE SULFATE | 03J5ZE7KA5 | ACTIB |
| SCOPOLAMINE HYDROBROMIDE | 451IFR0GXB | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN SODIUM | CR6K9C2NHK | IACT |
| PROPYLPARABEN SODIUM | 625NNB0G9N | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| REBAUDIOSIDE A | B3FUD0528F | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e1cfe604-29fb-4b3c-a90c-ecc78af8d92b | 873e5a08-e69b-46d0-a254-51b180d9232c | 2021-04-20 | Warnings, Adverse reactions | 873e5a08-e69b-46d0-a254-51b180d9232c |
Adverse event summaries are temporarily unavailable. Other product information remains available.