United States - English - NLM (National Library of Medicine)
PHOSPHASAL- methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate,
methylene blue, and hyoscyamine sulfate tablet
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.
tablets for oral administration
Each tablet contains:
Sodium Phosphate Monobasic
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; l-tropic acid ester with tropine; l-tropine tropate. C
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
; 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
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; Salol. C
; 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.
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; H
P; 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.
tablets contain inactive ingredients: Crospovidone, Dicalcium Phosphate, FD&C Blue #1
Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl
Alcohol, Stearic Acid, Talc, and Titanium Dioxide.
HYOSCYAMINE SULFATE is a parasympatholytic which relaxes smooth muscles and thus produces
an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed
throughout the body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being
unchanged. Its biotransformation is hepatic. Its protein binding is moderate.
METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides
bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70%-90%
reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is
almost completely (90%) excreted; of this at a pH of 5, approximately 20% is formaldehyde. Protein
binding - some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine
is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at
pH greater than 6.8.
METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed by the gastrointestinal
tract and rapidly reduced to leukomethylene blue which is stabilizied in some combination form in the
urine. 75% is excreted unchanged.
PHENYL SALICYLATE releases salicylate, a mild analgesic for pain.
SODIUM PHOSPHATE MONOBASIC an acidifier, helps to maintain an acid pH in the urine necessary
for the degradation of methenamine.
INDICATIONS AND USAGE
tablets 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
Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue
Cross sensitivity and/or related problems
patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay
in gastric emptying could complicate the management of gastric ulcers.
FDA Pregnancy Category C
hyoscyamine and methenamine cross the placenta. Studies concerning the effect of hyoscyamine and
methenamine on pregnancy and reproduction have not been done in animals or humans. Thus it is not
known whether Phosphasal
tablets cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity and should be given to a pregnant woman only if clearly needed.
problems in humans have not been documented; however, methenamine and traces of hyoscyamine are
excreted in breast milk. Accordingly, Phosphasal
tablets should be given to a nursing mother with
caution and only if clearly needed.
there have been no studies to establish the safety of prolonged use in humans. No known long-term
animal studies have been performed to valuate carcinogenic potential.
infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.
use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement,
agitation, drowsiness or confusion.
Cardiovascular: rapid heartbeat, flushing
Central Nervous System: blurred vision, dizziness, drowsiness
Genitourinary: difficult micturition, acute urinary retention
Gastrointestinal: dry mouth, nausea and vomiting
Respiratory: shortness of breath or trouble breathing
Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice
symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble
This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is
harmless and will subside after medication is stopped.
Call your doctor or physician for medical advice about side effects. To report SUSPECTED
ADVERSE REACTIONS, contact BioComp Pharma at 1-866-762-2365 or FDA at 1-800-FDA-
because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the
absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics
(may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its
conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of
hyoscyamine because of secondary antimuscarinic activities of these medications);
antacids/antidiarrheals (may reduce absorption of hyoscyamine, concurrent use with antacids may cause
urine to become alkaline, reducing effectiveness of methenamine by inhibiting its conversion to
formaldehyde). Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine;
antimyasthenics (concurrent use with hyoscyamine may further reduce intestinal motility); ketoconazole
(patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine
oxidase (MAO) inhibitors (concurrent use may intensify antimuscarinic side effects), opioid (narcotic
analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may
precipitate with formaldehyde in the urine, increasing the danger of crystalluria). Patients should be
advised that the urine may become blue to blue-green and the feces may be discolored as a result of the
excretion of the Methylene blue.
DRUG ABUSE AND DEPENDENCE
A dependence on the use of Phosphasal
tablets has not been reported and due to the nature of its
ingredients, abuse of Phosphasal
tablets is not expected.
Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5
to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms.
Administration of small doses of diazepam to control excitement and seizures. Artificial respiration
with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as
If overdose is suspected, contact your local poison center or emergency room immediately. US
residents can contact the US National Poison Hotline at 1-800-222-1222.
tablets are blue tablets imprinted with "SAT" on one side and "902" on opposite side.
NDC 44523-742-01, Bottle of 100 Tablets.
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.
DOSAGE AND ADMINISTRATION
Adults - one tablet orally 4 times per day followed by liberal fluid intake.
Older Children - Dosage must be individualized by physician. Not recommended for use in children
six years of age or younger.
Phosphasal Bottle Label
WARNING: Keep this and all drugs out of reach of children.
BIOCOMP PHARMA, INC.
San Antonio, Texas 78230
methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)
(SODIUM CATION - UNII:LYR4M0 NH37)
SODIUM PHOSPHATE, MONOBASIC,
40 .8 mg
PHENYL SALICYLATE (UNII: 28 A37T47QO) (PHENYL SALICYLATE -
36 .2 mg
HYO SCYAMINE SULFATE (UNII: F2R8 V8 2B8 4) (HYOSCYAMINE -
UNII:PX44XO8 46 X)
0 .12 mg
METHYLENE BLUE (UNII: T42P9 9 26 6 K) (METHYLENE BLUE CATION -
UNII:ZMZ79 8 9 1ZH)
10 .8 mg
METHENAMINE (UNII: J50 OIX9 5QV) (METHENAMINE - UNII:J50 OIX9 5QV)
8 1.6 mg
Stre ng th
CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)
ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)
ALUMINUM O XIDE (UNII: LMI26 O6 9 33)
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)
PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )
STEARIC ACID (UNII: 4ELV7Z6 5AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
no sco re
S hap e
S iz e
SAT;9 0 2
Marketing Start Date
Marketing End Date
10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 9 /21/20 10
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
unappro ved drug o ther
0 9 /21/20 10
BioComp Pharma (829249718)