phenylephrine tannate, pyrilamine tannate
Dosage Form: tablet, suspension
Ryna®-12
Tablets
Ryna-12 S®
Suspension
IN-0673-03 Rev. 3/09
Description
RYNA®-12 is an antihistamine/nasal decongestant combination available for oral administration as Tablets and as Suspension. Each tablet contains:
Phenylephrine Tannate 25 mg
Pyrilamine Tannate 60 mg
Other ingredients: corn starch, dibasic calcium phosphate, magnesium stearate, methylcellulose, polygalacturonic acid, talc.
Each 5 mL (one teaspoonful) of the pink-colored, natural strawberry-artificial currant flavored Suspension contains:
Phenylephrine Tannate 5 mg
Pyrilamine Tannate 30 mg
Other ingredients: benzoic acid, FD&C Red No. 3, flavors (natural and artificial), glycerin, kaolin, magnesium aluminum silicate, methylparaben, pectin, purified water, saccharin sodium, sucrose.
Clinical Pharmacology
RYNA®-12 combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of pyrilamine.
Indications and Usage
RYNA®-12 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.
Contraindications
RYNA®-12 is 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. These products contain 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 these products. Patients should be warned not to use these products 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 RYNA®-12.
Pregnancy: Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with RYNA®-12. It is also not known whether RYNA®-12 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RYNA®-12 should be given to a pregnant woman only if clearly needed.
Nursing mothers: RYNA®-12 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 RYNA®-12 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.
RYNA®-12 Tablets: Adults — 1 or 2 tablets.
Children 6 to 11 years — 1/2 or 1 tablet. Ryna-12 S ® Suspension: Children over six 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.
How Supplied
RYNA®-12 Tablets (phenylephrine tannate 25 mg, and pyrilamine tannate 60 mg): buff-colored, capsule-shaped, scored on one side and imprinted WALLACE 673 on the other side. The tablets are available in bottles of 100 (NDC 0037-0673-10).
Ryna-12 S® Suspension (phenylephrine tannate 5 mg, and pyrilamine tannate 30 mg per 5 mL) in 4 fl oz unit of use container with a 10 mL graduated oral syringe and fitment (NDC 0037-0655-04, labeled Ryna-12 S®).
Storage: RYNA®-12 Tablets — Store at controlled room temperature 20°-25°C (68°-77°F).
Ryna-12 S® Suspension — Store at controlled room temperature 20°-25°C (68°-77°F).
U.S. Patent 6,287,597
Produced under license from
JFC Technologies
Bound Brook, NJ, U.S.A.
U.S. Patents 5,599,846; 5,663,415
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.
MEDA
PHARMACEUTICALS®
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120
Printed in U.S.A. Rev. 3/09
Package Label - Principal Display Panel – 4 fl. oz. Bottle, Ryna-12 S Suspension
NDC 0037-0655-04
4 fl oz (118 mL)
Ryna-12 S®
SUSPENSION
Each 5 mL (teaspoonful)
contains:
Phenylephrine Tannate 5 mg
Pyrilamine Tannate 30 mg
U.S. Patent 6,287,597
Rx Only
SHAKE WELL
LB-065504-04 Rev. 10/03
Usual Dosage:
See full prescribing information on bottom of tray.
See enclosed patient instructions for use of fitment and syringe.
Store at controlled room temperature 20°-25°C (68°-77°F).
Produced under license from
JFC Technologies
Bound Brook, NJ, U.S.A.
U.S. Patents 5,599,846; 5,663,415
MedPointe Pharmaceuticals
MedPointe Healthcare Inc.
Somerset, New Jersey 08873
Package Label - Principal Display Panel – 4 fl oz Carton, Ryna-12 S Suspension
NDC 0037-0655-04
4 fl oz (118 mL)
Ryna-12 S®
SUSPENSION
Each 5 mL (teaspoonful) contains:
Phenylephrine Tannate 5 mg
Pyrilamine Tannate 30 mg
U.S. Patent 6,287,597
Rx Only
See enclosed patient instructions for use
of fitment and syringe.
SHAKE WELL
Package Label - Principal Display Panel – 100-ct Bottle, Ryna-12 Tablets
NDC 0037-0673-10
100 Tablets
RYNA®-12
Each tablet contains:
Phenylephrine Tannate 25 mg
Pyrilamine Tannate 60 mg
U.S. Patent 6,287,597
Rx Only
LB-067310-02 Rev. 10/03
USUAL DOSE: See package insert.
Store at controlled room tempera-
ture 20°-25°C (68°-77°F).
Protect from moisture.
Dispense in a tight container.
Produced under license from
JFC Technologies
Bound Brook, NJ, U.S.A.
U.S. Patents 5,599,846; 5,663,415
MedPointe Pharmaceuticals
MedPointe Healthcare Inc.
Somerset, New Jersey 08873
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| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 09/01/1999 | ||
| RYNA -12 phenylephrine tannate and pyrilamine tannate tablet | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 09/01/2002 | ||
| Labeler - Meda Pharmaceuticals Inc. (051229602) |
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