USTELL- methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate capsul

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

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Download Vara einkenni (SPC)
10-01-2017

Virkt innihaldsefni:

METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV), SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (SODIUM CATION - UNII:LYR4M0NH37), PHENYL SALICYLATE (UNII: 28A37T47QO) (PHENYL SALICYLATE - UNII:28A37T47QO), METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH), HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)

Fáanlegur frá:

Star Pharmaceuticals LLC

INN (Alþjóðlegt nafn):

METHENAMINE

Samsetning:

METHENAMINE 120 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Ustell™ capsules are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures. Hypersensitivity to any of the ingredients is possible. Risk benefits should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis, acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy). A dependence on the use of Ustell™ capsules has not been reported and due to the nature of its ingredients, abuse of Ustell™ capsules is not expected.

Vörulýsing:

Ustell™ capsules are blue-blue capsules imprinted with "S903". NDC 0076-0903-01, Bottle of 100 capsules. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15°-30°C (59°- 86°F). Keep in a cool, dry place. Keep container tightly closed. WARNING: Keep this and all drugs out of reach of children.

Leyfisstaða:

unapproved drug other

Vara einkenni

                                USTELL- METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL
SALICYLATE,
METHYLENE BLUE, AND HYOSCYAMINE SULFATE CAPSULE
STAR PHARMACEUTICALS LLC
_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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US TELL™
RX ONLY
100 CAPSULES
DESCRIPTION
USTELL™ Capsules for oral administration
Each capsule contains:
Methenamine
120 mg
Sodium Phosphate Monobasic
40.8 mg
Phenyl Salicylate
36 mg
Methylene Blue
10 mg
Hyoscyamine Sulfate
0.12 mg
HYOSCYAMINE SULFATE.
[620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-
8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt);
1αH,5αH-tropan-3α-ol(-)-tropate(ester)
sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester
with tropine; I-tropine tropate. C
H
N
O
S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white
crystalline powder. Its
solutions are alkaline to litmus. Affected by light, it is slightly
soluble in water; freely soluble in
alcohol; sparingly soluble in ether.
METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1
] decane; hexamethylenetetramine;
HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine;
Uritone; Urotropin. C
H
N
; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine
(hexamethylenetetramine) exists as
colorless, lustrous crystals or white crystalline powder. Its
solutions are alkaline to litmus. Freely
soluble in water, soluble in alcohol and in chloroform.
METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium
chloride; C.I. Basic Blue
9; methylthioninium chloride; tetramethylthionine chloride;
3,7-bis(dimethylamino) phenazathionium
chloride. C
H
ClN
S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%.
Methylene Blue (Methylthionine chloride) exists as dark green
crystals. It is soluble in water and in
chloroform; sparingly soluble in alcohol.
PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester;

                                
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