 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phenylephrine, Chlorpheniramine, and Pyrilamine
R- TANNATE is an antihistaminic / decongestant combination available for oral administration as Tablets and as Pediatric Suspension. Each tablet contains: Other ingredients: Cellulose, croscarmellose, guar gum, anhydrous lactose, magnesium stearate, microcrystalline cellulose. Each 5 mL (teaspoonful) of the Pediatric Suspension contains: Other ingredients: Citric acid,
D&C Red #28, disodium edta, flavors, glycerin, magnesium
aluminum silicate,
methylparaben, purified water, sodium
benzoate, sodium citrate,
sodium saccharin, sorbitol,
sucrose, xanthan gum.
R-TANNATE combines the sympathomimetic
decongestant effect
of phenylephrine with the antihistaminic
actions of chlorpheniramine and pyrilamine.
R-TANNATE is indicated for symptomatic relief of the coryza and nasal congestion associated with the common cold, sinusitis, allergic rhinitis and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease.
Administer the recommended dose every 12 hours. R-TANNATE Tablets Adults 1 or 2 tablets. R-TANNATE Pediatric Suspension HOW SUPPLIED R-TANNATE Tablets: off-white to beige capsule-shaped tablets debossed “COPLEY 113” on one side and plain and scored on the other side, in bottles of 100. R-TANNATE Pediatric Suspension: pink, strawberry-blackberry-currant flavored liquid for oral administration in 118 mL (4 fl oz) unit-of-use bottles (NDC 51285-717-55, labeled TRIOTANN-S); and in 473 mL (1 pt) bottles (NDC 51285-717-57, labeled TRIOTANN, NDC 0839-7309-69, labeled MOORETAN, and NDC 0364-2197-16, labeled R-TANNATE, NDC 0904-7650-16, labeled RHINATATE). Storage R-TANNATE Tablets Store at room temperature; avoid excessive heat (above 40° C/104° F). R-TANNATE Pediatric Suspension Store at controlled room temperature between 15°-30° C(59°-86° F); protect from freezing. Dispense in tight container. CAUTION: Federal law prohibits
dispensing without prescription.
Adverse effects associated with R-TANNATE 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.
Do not prescribe
this product for use
in patients that are now taking a prescription
M.O. (certain drugs for
depression, psychiatric
or emotional conditions, or Parkinson’s disease), or for 2 weeks
after stopping the MAOI drug
therapy. M.O. inhibitors
may prolong or intensify the anticholinergic effects of antihistamines
and the overall effects of sympathomimetic
agents.
Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow angle glaucoma or prostatic hypertrophy. Use with caution or avoid use in patients taking monoamine oxidase inhibitors (MAOI). This product contains antihistamines which may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e. g., hypnotics, sedatives, tranquilizers).
General Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients. Antihistamines may cause excitation, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. Carcinogenesis, Mutagenesis, Impairment of Fertility No long term animal studies have been performed with R-TANNATE. Pregnancy Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with R-TANNATE. It is also not known whether R-TANNATE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. R-TANNATE should be given to a pregnant woman only if clearly needed. Nursing Mothers R-TANNATE should not be administered to a nursing
mother.
|
| |||