C-TANNA 12D SUSPENSION
-
carbetapentane tannate,
pyrilamine tannate and
phenylephrine tannate suspension
Prasco Laboratories
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C-Tanna 12D TabletsC-Tanna 12D Suspension
11 DESCRIPTION
C-Tanna 12D is an antitussive/antihistamine/nasal decongestant combination available for oral administration as Tablets and as a Suspension.
Each tablet contains:
Carbetapentane Tannate 60 mg
Pyrilamine Tannate 40 mg
Phenylephrine Tannate 10 mg
Other ingredients: corn starch, dibasic calcium phosphate, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40, magnesium stearate, methylcellulose, polygalacturonic acid, povidone, silicon dioxide, talc.
Each 5 mL (one teaspoonful) of the suspension contains:
Carbetapentane Tannate 30 mg
Pyrilamine Tannate 30 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.
12 CLINICAL PHARMACOLOGY
C-Tanna 12D Tablets and C-Tanna 12D Suspension combine the antitussive action of carbetapentane, the sympathomimetic decongestant effect of phenylephrine, and the antihistaminic action of pyrilamine.
1 INDICATIONS & USAGE
C-Tanna 12D Tablets and C-Tanna 12D 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.
4 CONTRAINDICATIONS
C-Tanna 12D Tablets and C-Tanna 12D Suspension are contraindicated for newborns, nursing mothers, and patients who are sensitive to any of the ingredients or related compounds.
WARNINGS
Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow angle glaucoma, or prostatic hypertrophy. Do nut use in patients taking monoamine oxidase (MAO) inhibitors, or for 14 days after stopping treatment with an MAOI.
This product contains 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).
PRECAUTIONS
C-Tanna 12D 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 PRECAUTIONS
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.
17 INFORMATION FOR PATIENTS
Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a care or operating machinery, while using this product. Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression psychiatric or emotional conditions, or Parkinson’s 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.
7 DRUG INTERACTIONS
MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and sympathomimetics.
1 CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
No long term animal studies have been performed with C-Tanna 12D Tablets or C-Tanna 12D Suspension.
Pregnancy: Teratogenic effects: Pregnancy Category C.
Animal reproduction studies have not been conducted with C-Tanna 12D Tablets or C-Tanna 12D Suspension. It is also not known whether C-Tanna 12D Tablets or C-Tanna 12D Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. C-Tanna 12D Tablets or C-Tanna 12D Suspension should be given to a pregnant woman only if clearly needed.
3 NURSING MOTHERS
C-Tanna 12D Tablets or C-Tanna 12D Suspension should not be administered to a nursing woman.
6 ADVERSE REACTIONS
Adverse reactions may include drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare.
10 OVERDOSAGE
Signs and symptoms: May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead convulsions and death. Atropine-like signs and symptoms may be prominent.
Treatment: Induce vomiting if it has not occurred spontaneously. 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.
2 DOSAGE & ADMINISTRATION
Administer the recommended dose every 12 hours.
C-Tanna 12D Tablets:
Adults and children 12 years and older – 1 to 2 tablets.
Children 6 to 11 years – ½ to 1 tablet.
C-Tanna 12D Suspension:
Over 6 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.
16 HOW SUPPLIED
C-Tanna 12D Tablets are pink-colored, capsule-shaped, scored on one side and imprinted PRASCO 552 on the other side, containing in each tablet: carbetapentane tannate 60 mg, pyrilamine tannate 40 mg, phenylephrine tannate 10 mg, available in bottles of 100 (NDC 66993-552-02).
C-Tanna 12D Suspension is pink with strawberry-currant flavor, containing in each 5 mL (one teaspoonful): carbetapentane tannate 30 mg, pyrilamine tannate 30 mg, pheylephrine tannate 5 mg, available in 4 fl oz unit of use containers (NDC66993-553-55).
Storage: Store at controlled room temperature 20°-25°C (68°-77°F).
Dispense in a tight container.
U.S.Patent 6,417, 206
Produced under license from
JFC Technologies
Bound Brook, NJ, U.S.A
U.S. Patents 5,599,846; 5,663, 415
Manufactured for:
Prasco Laboratories
Cincinnati, Ohio 45249 USA
Manufactured by:
Denver Chemical, Inc.
Decatur, Il 62525
Printed in U.S.A. Iss. 11/04
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
| C-TANNA 12D
SUSPENSION
carbetapentane tannate, pyrilamine tannate, phenylephrine tannate suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 01/01/2006 | 10/31/2008 | |
| Labeler - Prasco Laboratories (065969375) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Denver Chemical, Inc. | 005119771 | MANUFACTURE | |