PHENOBARBITAL WITH BELLADONNA ALKALOIDS elixir

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D), HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X), ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I), SCOPOLAMINE HYDROBROMIDE (UNII: 451IFR0GXB) (SCOPOLAMINE - UNII:DL48G20X8X)

Pieejams no:

AvKARE

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.

Produktu pārskats:

Phenobarbital with Belladonna Alkaloids Elixir is supplied as a purple colored, grape flavored liquid. 4 oz. bottles NDC: 42291-205-04 16 oz. (Pint) bottles NDC: 42291-205-16 AVOID FREEZING Store 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. All prescriptions using this product shall be pursuant to State statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on the therapeutic equivalence. 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 for: AvKARE Pulaski, TN 38478 Mfg. Rev. 01/18 AV 05/20 (P)

Autorizācija statuss:

unapproved drug other

Produkta apraksts

PHENOBARBITAL WITH BELLADONNA ALKALOIDS- PHENOBARBITAL WITH BELLADONNA
ALKALOIDS ELIXIR
AVKARE
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR
PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR
Rx Only
DESCRIPTION:
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
INACTIVE INGREDIENTS:
Ethyl Alcohol, Purified Water, Glycerin, Methylparaben Sodium,
Propylparaben Sodium, Saccharin
Sodium, Xylitol, Citric Acid, Stevia Reb-A, Natural and Artificial
Grape Flavor
CLINICAL PHARMACOLOGY:
This drug combination provides natural belladonna alkaloids in a
specific, fixed ratio combined with
phenobarbital to provide peripheral anticholinergic/antispasmodic
action and mild sedation.
INDICATIONS AND USAGE:
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:
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 her