R-TANNA — phenylephrine tannate and chlorpheniramine tannate tablet
Physicians Total Care, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.


R-Tanna Tablets are an 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

R-Tanna Tablets combine the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of chlorpheniramine.

R-Tanna Indications and Usage

R-Tanna Tablets are 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.


R-Tanna Tablets are contraindicated for newborns, nursing mothers and patients 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. Use with caution or avoid use in patients taking monoamine oxidase (MAO) inhibitors, or within 14 days of stopping such treatment. 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).


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.

Adverse Reactions to R-Tanna

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.

Adverse effects associated with R-Tanna Tablets 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 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

Administer the recommended dose every 12 hours.

R-Tanna Tablets: Adults — 1 or 2 tablets.

How Supplied

R-Tanna Tablets (phenylephrine tannate 25 mg, chlorpheniramine tannate 9 mg): buff-colored, capsule-shaped, and imprinted “PRASCO 534″ on one side and bisected on the other side. The tablets are available in

Bottles of 20NDC 54868-2189-2
Bottles of 30NDC 54868-2189-3
Bottles of 40NDC 54868-2189-0
Bottles of 60NDC 54868-2189-1

Storage: Store at controlled room temperature 20°-25°C (68°-77°F). Protect from moisture.

Dispense in a tight container.

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 .

U.S. Patent 6,037,358

Produced under license from

JFC Technologies

Bound Brook, NJ, U.S.A.

U.S. Patents 5,599,846; 5,663,415

Mfd. For: Prasco Laboratories

Mason, OH 45040 USA

Mfd. By: Meda Pharmaceuticals Inc.

Somerset, New Jersey 08873-4120

Rev. 05/10

Relabeling and Repackaging by:

Physicians Total Care, Inc.

Tulsa, OK 74146

Package Label — Principal Display Panel — R-Tannamine Tablets

R-Tannmine Tablets

(phenylephrine tannate 25 mg, chlorpheniramine tannate 9 mg)

image of package label
(click image for full-size original)
R-TANNA phenylephrine tannate and chlorpheniramine tannate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-2189(NDC:66993-534)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color brown (buff) Score 2 pieces
Shape CAPSULE Size 15mm
Flavor Imprint Code PRASCO534
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2189-0 40 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-2189-1 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-2189-2 20 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-2189-3 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/16/1996
Labeler — Physicians Total Care, Inc. (194123980)
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 08/2010 Physicians Total Care, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.