Trital SR

Each extended release tablet for oral administration contains:

in a specially prepared base, to provide a prolonged therapeutic effect.

Acetaminophen, 4'-Hydroxyacetanilide, is a non-opiate, non-salicylate. It has the following structural formula:

C8H9NO2    M.W. 151.16

Chlorpheniramine maleate, 2-Pyridinepropanamine, γ-(4-chlorphenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1), is an antihistamine. It has the following structural formula:

C16H19CIN2 • C4H4O4    M.W. 390.86

Phenylephrine hydrochloride, Benzenemethanol, 3-hydroxy- α-[(methylamino) methyl]-, hydrochloride (R)-, is a sympathomimetic amine. It has the following structural formula:

C9H13NO2 • HCL    M.W.=203.67

Phenyltoloxamine citrate, N, N-dimethyl-2- (α-phenyl-o-tolyloxy) ethylamine dihydrogen citrate, is an adjuvant to acetaminophen. it has the following structural formula:

C17H21NO • C6H8O7    M.W. 447.47

Also includes the following as inactive ingredients: croscarmellose sodium, dicalcium phosphate, 1FD&C yellow No. 5, hypromellose, microcrystalline cellulose, silicon dioxide, stearic acid and talc.

The mechanism of analgesic action of acetaminophen has not been fully determined. Acetaminophen may act by inhibiting prostaglandin synthesis in the central nervous system (CNS) and, through peripheral action, by blocking pain-impulse generation. The peripheral action may be due to inhibition of the syntheses of prostaglandins or to inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation.

Chlorpheniramine maleate is an alkylamine-type antihistamine. This group of antihistamines is among the most active histamine antagonists and are generally effective in relatively low doses.

Phenylephrine hydrochloride is primarily a direct acting sympathomimetic amine.

Sympathomimetic amines act on alpha adrenergic receptors in the mucosa of the respiratory tract to produce vasoconstriction, which temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal passages. Phenyltoloxamine citrate is an ethanol amine-type compound used as an adjuvant with acetaminophen to mediate the release of bradykinin and prostaglandin, two agents involved in the cause of inflammatory pain.

Trital™ SR should not be administered to patients who have previously exhibited hypersensitivity to any of the ingredients Risk-benefit should be considered when any of the following medical problems exist: alcoholism, asthma, bladder-neck obstruction, urinary retention, cardiovascular disease, diabetes mellitus, glaucoma, hepatic function impairment, hypertension, hyperthyroidism, prostatic hypertrophy, psychosis or other psychiatric disorders, renal function impairment, viral hepatitis.

Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. If pain or fever persist, if new symptoms occur, or if redness or swelling is present, consult your physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age. Caution should be exercised when used in patients with prostatic hypertrophy, urinary retention, bladder neck obstruction, increased ocular pressure and asthma.

Alcohol Warning

If you consume 3 or more alcoholic drinks every day, ask you doctor whether you should take acetaminophen or other pain relievers/ fever reducers. Acetaminophen may cause liver damage.

Trital™ SR is a yellow, triangle-shaped tablet debossed B529 on one side and scored on the opposite. Available in bottles of 100, NDC 51991-529-01.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Dispense in tight, light-resistant containers as defined in the USP/NF with a child-resistant closure.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Manufactured by:
Provident Pharmaceuticals, LLC
Colorado Springs, CO 80919

PI235

Iss: 02/08

Breckenridge
Pharmaceutical, Inc.

NDC 51991-529-01

Trital™ SR

Antihistamine/Analgesic
Decongestant

Each extended release tablet for oral
administration contains:

100 TABLETS
Rx Only