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Rynatan Chewable Pediatric Tablets

Generic Name: phenylephrine tannate and chlorpheniramine tannate
Dosage Form: chewable tablet

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.

RYNATAN®
Chewable
Pediatric Tablets
 
IN-0712-05          Rev. 1/09

Description

Rynatan® Chewable Pediatric Tablets are an antihistamine/nasal decongestant combination. Each grape flavored chewable tablet contains:

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Phenylephrine Tannate                  5 mg
Chlorpheniramine Tannate          4.5 mg

Other ingredients: FD&C Blue No. 2, FD&C Red No. 40, flavor (artificial), magnesium stearate, maltodextrin, saccharin sodium, sodium starch glycolate, sucrose, talc.

Clinical Pharmacology

Rynatan® Chewable Pediatric Tablets combine the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of chlorpheniramine.

Indications and Usage

Rynatan® Chewable Pediatric 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.

Contraindications

Rynatan® Chewable Pediatric Tablets are contraindicated for newborns, nursing mothers and patients 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. 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).

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 Rynatan® Chewable Pediatric Tablets.

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

Nursing mothers: Rynatan® Chewable Pediatric Tablets should not be administered to a nursing woman.

Adverse Reactions

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 the Rynatan® Chewable Pediatric Tablets antihistamine and sympathomimetic ingredients 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.

Overdosage

Signs & 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.

Rynatan® Chewable Pediatric Tablets: Children over six years of age – 1 to 2 chewable tablets; Children two to six years of age – 1/2 or 1 chewable tablet.

How Supplied

Rynatan® Chewable Pediatric Tablets (phenylephrine tannate 5 mg, and chlorpheniramine tannate 4.5 mg): purple-colored, caplet-shaped, scored on one side and imprinted RYNATAN 712 on the other side. The chewable tablets are available in bottles of 30 (NDC 0037-0712-03).

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

Dispense in a tight container.

Protect from moisture.

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.

Produced under license from
JFC Technologies
Bound Brook, NJ, U.S.A.
U.S. Patents 5,599,846; 5,663,415

MEDA Pharmaceuticals®
Meda Pharmaceuticals Inc.

Somerset, New Jersey 08873-4120
Printed in U.S.A.          Rev. 1/09

Package Label - Principal Display Panel – 30 Tablet Bottle

NDC 0037-0712-03
RYNATAN®
CHEWABLE
Pediatric Tablets

(phenylephrine tannate,
chlorpheniramine tannate)
30 Tablets
Each tablet contains:
Phenylephrine Tannate, 5 mg
Chlorpheniramine Tannate, 4.5 mg
Rx only
MEDA Pharmaceuticals®
Meda Pharmaceuticals Inc.

Somerset, New Jersey 08873-4120
LB-071203-05     Rev. 1/09
Usual Dose: See package insert.
Store at controlled room temperature
20°-25°C (68°-77°F).
Dispense in a tight container.
Protect from moisture.
Produced under license from
JFC Technologies
Bound Brook, NJ, U.S.A.
U.S. Patents 5,599,846; 5,663,415

RYNATAN   CHEWABLE PEDIATRIC
phenylephrine tannate and chlorpheniramine tannate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-0712
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE TANNATE (PHENYLEPHRINE) PHENYLEPHRINE TANNATE 5 mg
CHLORPHENIRAMINE TANNATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE TANNATE 4.5 mg
Product Characteristics
Color PURPLE Score 2 pieces
Shape CAPSULE Size 15mm
Flavor GRAPE Imprint Code RYNATAN;712
Contains         
Packaging
# Item Code Package Description
1 NDC:0037-0712-03 30 TABLET (30 TABLET) in 1 BOTTLE
2 NDC:0037-0712-12 10 PACKET (PACKET) in 1 BOX
2 2 POUCH (POUCH) in 1 PACKET
2 1 TABLET (2 TABLET) in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/24/2005 09/30/2012
Labeler - Meda Pharmaceuticals Inc. (051229602)
Revised: 06/2011
 
Meda Pharmaceuticals Inc.

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