TUSSI-12® is an antitussive/antihistamine/nasal decongestant combination available for oral administration as Tablets and as a Suspension.
Each tablet contains:
Carbetapentane Tannate 60 mg
Chlorpheniramine Tannate 5 mg
Phenylephrine Tannate 10 mg
Other ingredients: corn starch, dibasic calcium phosphate, FD&C Blue No. 1, FD&C Red No. 40, magnesium stearate, methylcellulose, polygalacturonic acid, povidone, talc.
Each 5 mL (one teaspoonful) of the suspension contains:
Carbetapentane Tannate 30 mg
Chlorpheniramine Tannate 4 mg
Phenylephrine Tannate 5 mg
Other ingredients: benzoic acid, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40, FD&C Yellow No. 5 (see Precautions ), flavors (natural and artificial), glycerin, kaolin, magnesium aluminum silicate, methylparaben, pectin, purified water, saccharin sodium, sucrose.
TUSSI-12 Tablets and Suspension combine the antitussive action of carbetapentane, the sympathomimetic decongestant effect of phenylephrine, and the antihistaminic action of chlorpheniramine.
TUSSI-12 Tablets and Suspension are indicated for the symptomatic relief of cough associated with respiratory tract conditions such as the common cold, bronchial asthma, acute and chronic bronchitis. Appropriate therapy should be provided for the primary disease.
TUSSI-12 Tablets and Suspension are contraindicated for newborns, nursing mothers, and patients who are sensitive to any of the ingredients or related compounds.
Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow angle glaucoma, or prostatic hypertrophy. Do not use in patients taking monoamine oxidase (MAO) inhibitors, or for 14 days after stopping treatment with an MAOI.
These products contain an antihistamine which may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers).
TUSSI-12 Suspension contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
General: Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. Antihistamines may cause excitation, particularly in children, but their combination with sympathomimetics may cause either mild stimulation or mild sedation.
Information for patients: Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery, while using these products. Patients should be warned not to use these products if they are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson' disease), or for 2 weeks after stopping the MAOI drug. If patients are uncertain whether a prescription drug contains an MAOI, they should be instructed to consult a health professional before taking such a product.
Drug interactions: MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents.
Carcinogenesis, mutagenesis, impairment of fertility: No long term animal studies have been performed with TUSSI-12 Tablets or Suspension.
Pregnancy: Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with TUSSI-12 Tablets or Suspension. It is also not known whether TUSSI-12 Tablets or Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TUSSI-12 Tablets or Suspension should be given to a pregnant woman only if clearly needed.
Nursing mothers: TUSSI-12 Tablets or Suspension should not be administered to a nursing woman.
Adverse effects associated with TUSSI-12 Tablets or Suspension at recommended doses have been minimal. The most common have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare.
Signs and symptoms: May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent.
Treatment Induce vomiting if it has not occurred spontan-eously. Precautions must be taken against aspiration especially in infants, children, and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.
Administer the recommended dose every 12 hours.
TUSSI-12® Tablets: Adults--1 to 2 tablets.
TUSSI-12 Suspension: Over six years of age --5 to 10 mL (1 to 2 teaspoonfuls); Children two to six years of age --2.5 to 5 mL (1/2 to 1 teaspoonful); Children under two years of age --Titrate dose individually.
TUSSI-12® Tablets are mauve, capsule-shaped, scored on one side and imprinted WALLACE 0640 on the other side, containing in each tablet: carbetapentane tannate 60 mg, chlorpheniramine tannate 5 mg, phenylephrine tannate 10 mg, available in bottles of 100 (NDC 0037-0640-10).
TUSSI-12® Suspension is pink with strawberry-currant flavor, containing in each 5 mL (one teaspoonful): carbetapentane tannate 30 mg, chlorpheniramine tannate 4 mg, phenylephrine tannate 5 mg, available in pint bottles (NDC 0037-0642-16).
Storage Store at controlled room temperature 20°-25°C (68°-77°F).
Dispense in a tight container.
PATENT PENDING
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WALLACE LABORATORIES Division of CARTER-WALLACE, INC. Cranbury, New Jersey 08512 |
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| IN-0642-04 |
Rev. 7/99
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