Ryna-12 S

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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.

RYNA®-12 combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of pyrilamine.

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.

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

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

Applies to phenylephrine / pyrilamine: oral liquid, oral suspension, oral suspension extended release, oral tablet, oral tablet chewable, oral tablet chewable extended release

Cardiovascular

Cardiovascular side effects have included hypotension, hypertension, cardiac arrhythmias and palpitations.[Ref]

Dermatologic

Dermatologic side effects have included urticaria, drug rash, photosensitivity and pruritus.[Ref]

Gastrointestinal

Gastrointestinal side effects have included epigastric discomfort, anorexia, vomiting, diarrhea, and constipation.[Ref]

Genitourinary

Genitourinary side effects have included urinary frequency and difficult urination.[Ref]

Nervous system

Nervous system side effects have included drowsiness, sedation, disturbed coordination, tremor, irritability, insomnia, nervousness, convulsions, headache, euphoria, and dysphoria.[Ref]

Ocular

Ocular side effects have included visual disturbances.[Ref]

Hematologic

Hematologic side effects have included hemolytic anemia, thrombocytopenia, and agranulocytosis.[Ref]

Respiratory

Respiratory side effects have included tightness of chest, wheezing, and shortness of breath.[Ref]

General

General side effects have included dryness of mucous membranes.[Ref]

Some side effects of Ryna-12S may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.