Based on the National Academy of Sciences-National Research Council's review of this drug and/or other information, 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 HA...
One or two teaspoonfuls of PHENOHYTRO ® 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
www.fda.gov/medwatchRx Only
each 5 mL (teaspoonful) oral-administered dose of elixir contains:
| Phenobarbital, USP (WARNING: may be habit forming) | 16.2 mg |
| Hyoscyamine Sulfate, USP | 0.1037 mg |
| Atropine Sulfate, USP | 0.0194 mg |
| Scopolamine Hydrobromide, USP | 0.0065 mg |
| Alcohol not more than 23.8% |
Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium saccharin, artificial grape flavor, FD&C Red No. 3, FD&C Blue No. 1.
each 5 mL (teaspoonful) oral-administered dose of elixir contains:
| Phenobarbital, USP (WARNING: may be habit forming) | 16.2 mg |
| Hyoscyamine Sulfate, USP | 0.1037 mg |
| Atropine Sulfate, USP | 0.0194 mg |
| Scopolamine Hydrobromide, USP | 0.0065 mg |
| Alcohol not more than 23.8% |
Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium saccharin, artificial mint flavor, FD&C Yellow No. 5, FD&C Blue No. 1.
Phenobarbital is a barbiturate with the chemical name 2,4,6(1H,3H,5H) -Pyrimidinetrione, 5-ethyl-5-phenyl-. It has the following structural formula:
| C12H12N2O3 |
| M.W. 232.2 |
Hyoscyamine sulfate is a belladonna alkaloid with the chemical name Benzeneacetic acid, α-(hydroxmethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate. It has the following structural formula:
| |
| (C17H23NO3)2 ∙ H2SO4 ∙ 2H2O | M.W. 712.85 |
Atropine sulfate is belladonna alkaloid with the chemical name: Benzeneacetic acid, α-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester. It has the following structural formula:
| |
| (C34H46N2O6 ∙ H2O4S ∙ H2O | M.W. 694.83 |
Scopolamine hydrobromide is a belladonna alkaloid with the chemical name Benezeneacetic acid, α-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo[3.31.0.2,4]non-[7-yl ester, hydrobromide, trihydrate, [7(S)-(1α,2β,4β,5α,7β)]-. It has the following structural formula:
| |
| C17H21NO4 ∙ BrH ∙ 3H2O | M.W. 438.31 |
This drug combination provides phenobarbital combined with belladonna alkaloids in a specific, fixed ratio to provide anticholinergic/antispasmodic action and mild sedation.
Phenobarbital is a barbiturate, nonselective central nervous system depressant. It is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses.
Atropine Sulfate, Hyoscyamine Sulfate, and Scopolamine are belladonna alkaloids classified as anticholinergic, antimuscarinic drugs. They act to inhibit muscarinic actions of acetylcholine at postganglionic parasympathetic neuron effector sites. These drugs are also used as antispasmodics due to their anticholinergic action. They produce the effect in the body of reduced muscle spasms in the digestive or urinary tract, and reduced fluid secretions from certain glands or organs.
Based on the National Academy of Sciences-National Research Council's review of this drug and/or other information, 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.
PHENOHYTRO® 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.
PHENOHYTRO® ELIXIR is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis; intestinal atony; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; hiatal hernia associated with reflux esophagitis; obstructive disease of the gastrointestinal tract; or severe ulcerative colitis.
Heat prostration can occur with belladonna alkaloids in high temperatures.
Diarrhea may be an early symptom of incomplete intestinal obstruction, particularly in patients with ileostomy or colostomy. In this instance, treatment with this drug could be harmful.
PHENOHYTRO® 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 necessary 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.
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, a curare-like action may occur with overdosage.
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Animal reproduction studies have not been conducted with PHENOHYTRO® ELIXIR. It is not known whether PHENOHYTRO® ELIXIR can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PHENOHYTRO® 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, exercise caution when administering PHENOHYTRO® ELIXIR to a nursing woman.
Practitioners should give the following information and instructions to patients:
Call your doctor for medical advice about side effects.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Winder Laboratories, LLC at 1-770-307-0702, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 PHENOHYTRO® 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 PHENOHYTRO® ELIXIR three or four times a day according to conditions and severity of symptoms.
may be dosed every 4 to 6 hours.
| 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 |
PHENOHYTRO® ELIXIR Mint Flavored is a green colored, mint flavored liquid.
NDC 17856-0123-01 Mint Flavored 5mL Cup 72
NDC 17856-0123-02 Mint Flavored 10mL Cup 72
AVOID FREEZING
Store PHENOHYTRO® ELIXIR at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser.
WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
IN THE CASE OF OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Contains color additives, including FD&C Yellow No. 5 (tartrazine).
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
20101 N.E 16TH PLACE
MIAMI, FL 33179
NDC 17856-0123-01
NDC 17856-0123-02
Phenohytro®
Elixir
Mint Flavored
Each 5 mL (1 teaspoonful) contains:
Phenobarbital, USP
16.2 mg
Hyoscyamine Sulfate, USP
0.1037 mg
Atropine Sulfate, USP
0.0194 mg
Scopolamine Hydrobromide, USP
0.0065 mg
Alcohol not more than 23.8%
DO NOT USE IF TAMPER-EVIDENT SEAL
UNDER CAP IS BROKEN OR MISSING
Rx Only
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1046787 | PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral Solution | PSN | 2 |
| 2048017 | Phenohytro 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution | PSN | 2 |
| 2048017 | atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution [Phenohytro] | SBD | 2 |
| 1046787 | atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution | SCD | 2 |
| 1046787 | atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral Solution | SY | 2 |
| 2048017 | Phenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral Solution | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ATROPINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| SCOPOLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c78bd43-efb4-4aeb-b7d8-eff1532f7822 | Product name | 4 | 20250801 |
| 41231c1e-8789-4da7-ac52-77fa90a85bf5 | Product name | 2 | 20250304 |
| fe8ea78e-e1a4-44bf-a6b2-42eed76976bb | Product name | 5 | 20250218 |
| e77ab9a2-80cf-4832-bff0-469bbc7cbcd0 | Product name | 2 | 20250214 |
| 5f84b7a7-523a-f042-dffb-1dadcd9b2407 | Product name | 4 | 20240110 |
| e3e67a66-d325-4d80-8f9d-059e736d7b00 | Product name | 1 | 20230912 |
| 0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca | Product name | 1 | 20230719 |
| 04cd5dc0-102f-46cb-8dbc-ca38dd2628d0 | Product name | 3 | 20230317 |
| dfd25202-b8d2-4628-9213-f3e0f9eafce5 | Product name | 4 | 20210513 |
| 4199bf9b-4718-828a-6dd6-ac2fbbd61687 | Product name | 1 | 20140508 |
| 4edd8af5-cea7-ae42-8023-e91c5335db1d | Product name | 1 | 20140508 |
| d3908afb-7784-440f-c406-88294732d36a | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-0123-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-fd19-0266-e053-dadaa90a7c1a | PHENOHYTRO ® ELIXIR |
| 17856-0123-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-fd19-0266-e053-dadaa90a7c1a | PHENOHYTRO ® ELIXIR |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0123-1 | Phenohytro | 5 mL in 1 CUP, UNIT-DOSE | ELIXIR | 5 | 2 | |
| 17856-0123-1 | Phenohytro | 72 in 1 BOX, UNIT-DOSE | ELIXIR | 72 | 2 | |
| 17856-0123-2 | Phenohytro | 10 mL in 1 CUP, UNIT-DOSE | ELIXIR | 10 | 2 | |
| 17856-0123-2 | Phenohytro | 72 in 1 BOX, UNIT-DOSE | ELIXIR | 72 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0123 | PHENOHYTRO (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDE) ELIXIR [ATLANTIC BIOLOGICALS CORP.] | 2 | Legacy NDC, 4 package rows | 20210113_d2c7febc-053e-4b22-9c99-af0e7fd9ce3f.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75826-128-04 | ML - Milliliter | 75826-128 | 613e03e0-1816-4b68-956e-da3afa817894 | 1 | 2018-07-03 |
| 75826-128-16 | ML - Milliliter | 75826-128 | 5e3689e7-3374-4fa4-827a-3e6f704bdb82 | 1 | 2018-07-03 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 17856-0123 | 17856-0123-1, 17856-0123-2 |
| 75826-128 |
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 |
| Glycerin | PDC6A3C0OX | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| Sucrose | C151H8M554 | IACT |
| Sorbitol | 506T60A25R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C Yellow No. 5 | I753WB2F1M | IACT |
| FD&C Blue No. 1 | H3R47K3TBD | IACT |
| Mint | FV98Z8GITP | 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 |
|---|---|---|---|---|---|---|
| 1ca4e527-6c78-41b9-8ecd-9a47607e1478 | d2c7febc-053e-4b22-9c99-af0e7fd9ce3f | 2021-01-12 | Warnings, Adverse reactions | 1ca4e527-6c78-41b9-8ecd-9a47607e1478 d2c7febc-053e-4b22-9c99-af0e7fd9ce3f | ||
| Phenohytro | PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDE | Winder Laboratories LLC | 29be31ef-108e-4b45-9ecc-b6d671da2826 | 2019-10-04 | Warnings, Adverse reactions | 75826-128 |
Adverse event summaries are temporarily unavailable. Other product information remains available.
