R-Tanna description, usages, side effects, indications, overdosage, supplying and lots more!

R-Tanna

Prasco Laboratories

R-Tanna Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Description

antihistamine/nasal decongestant combination. Each tablet contains:
Phenylephrine Tannate         25 mg
Chlorpheniramine Tannate      9 mg

Other ingredients: corn starch, dibasic calcium phosphate, magnesium stearate, methylcellulose, polygalacturonic acid, povidone, talc.

Clinical Pharmacology

Indications and Usage


Contraindications


Warnings


Precautions

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 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.

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 R-Tanna Tablets.

Pregnancy: Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with R-Tanna Tablets. It is also not known whether R-Tanna Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. R-Tanna Tablets should be given to a pregnant woman only if clearly needed.

Nursing mothers: R-Tanna Tablets should not be administered to a nursing woman.

Side Effects

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .



Overdosage

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 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.

Dosage and Administration



How Supplied



Storage:°°°°

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .







Mfd. For: Prasco Laboratories
             Mason, OH 45040 USA
Mfd. By: Meda Pharmaceuticals Inc.
             Somerset, New Jersey 08873-4120

Rev. 05/10

Package Label - Principal Display Panel - 100 Tablet Bottle, R-Tanna Tablets

Package Label - Principal Display Panel - 100 Tablet Bottle, R-Tanna Tablets

R-Tanna

Phenylephrine Tannate and Chlorpheniramine Tannate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:66993-534
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PHENYLEPHRINE TANNATE PHENYLEPHRINE 25 mg
CHLORPHENIRAMINE TANNATE CHLORPHENIRAMINE 9 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
METHYLCELLULOSE (1500 CPS)
povidone
talc

Product Characteristics

Color Size Imprint Code Shape
brown (buff) 15 mm PRASCO534 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66993-534-02 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2005-10-19


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