HYOLEV MB hyoscyamine sulfate methenamine methylene blue phenyl salicylate and sodium phosphate monobasic monohydrate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)

Available from:

Burel Pharmaceuticals, Inc

INN (International Name):

HYOSCYAMINE SULFATE

Composition:

HYOSCYAMINE SULFATE 0.12 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

HYOLEV MB- HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL
SALICYLATE, AND
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE TABLET
BUREL PHARMACEUTICALS, INC
_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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HYOLEV MB™ TABLETS
RX ONLY
Hyoscyamine Sulfate
0.12 mg
Methenamine
81.0 mg
Methylene Blue
10.8 mg
Phenyl Salicylate
32.4 mg
Sodium Phosphate Monobasic
40.8 mg
INACTIVE INGREDIENTS: LACTOSE, POLYETHYLENE GLYCOL, CROSPOVIDONE,
MAGNESIUM STEARATE, SILICON
DIOXIDE, FD&C BLUE # 1.
METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-13,7] decane;
hexamethylenetetramine;
HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine;
Uritone; Urotropin.
C6H12N4; 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.
SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt
(1:1); Sodium
biphosphate; sodium dihydrogen phosphate; acid sodium phosphate;
monosodium orthophosphate;
primary sodium phosphate; H2NaO4P; mol wt 119.98, H 1.68%, Na 19.16%,
O 53.34%, P 25.82%.
Monohydrate, white, odorless slightly deliquesce crystals or granules.
At 100° C loses all its water;
when ignited it converts to metaphosphate. It is freely soluble in
water and practically insoluble in
alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous
solution at 25° C: 4.5.
PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester;
Salol. C13H10O3; mol wt
214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus
oxy-chloride on a mixture
of phenol and salicylic acid. Phenyl Salicylate exists as white
crystals with a melting point of 41°-43°
C. It is very slightly soluble in water and freely soluble in alcohol.
METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) ph