PHENOHYTRO- phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide elixir

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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)

Disponibbli minn:

ATLANTIC BIOLOGICALS CORP.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 card

Sommarju tal-prodott:

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).

L-istatus ta 'awtorizzazzjoni:

unapproved drug other

Karatteristiċi tal-prodott

PHENOHYTRO- PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND
SCOPOLAMINE
HYDROBROMIDE ELIXIR
ATLANTIC BIOLOGICALS CORP.
_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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PHENOHYTRO ELIXIR
Rx Only
DESCRIPTION
PHENOHYTRO ELIXIR GRAPE FLAVORED
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%
INACTIVE INGREDIENTS
Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium
saccharin, artificial grape flavor,
FD&C Red No. 3, FD&C Blue No. 1.
DESCRIPTION
PHENOHYTRO ELIXIR MINT FLAVORED
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%
INACTIVE INGREDIENTS
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:
®
®
®
C
H N O
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:
(C
H NO ) · H SO · 2H O
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:
(C
H N O · H O S · H O
M.W. 694.83
Scopolamine hydrobromide is a belladonna alkaloid with the chemical
name Be