RYNATAN®-P Pediatric Suspension is an antihistamine/nasal decongestant combination available for oral administration as Pediatric Suspension . Each 5 mL (one teaspoonful) of the pink-colored natural strawberry- artificial currant flavored Pediatric Suspension contains:
Phenylephrine Tannate 5 mg
Chlorpheniramine Tannate 2 mg
Pyrilamine Tannate1 2.5 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.
RYNATAN®-P Pediatric Suspension combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic actions of chlorpheniramine and pyrilamine.
RYNATAN®-P Pediatric Suspension 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.
RYNATAN®-P Pediatric Suspension is contraindicated for newborns, nursing mothers and patients sensitive to any of the ingredients or related compounds.
Use with caution in patients with hypertension, cardio-vascular 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 antihistamines which may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypno-tics, 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' 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®-P Pediatric Suspension.
Pregnancy: Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with RYNATAN®-P Pediatric Suspension. It is also not known whether RYNATAN®-P Pediatric Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RYNATAN®-P Pediatric Suspension should be given to a pregnant woman only if clearly needed.
Nursing mothers: RYNATAN®-P Pediatric Suspension should not be administered to a nursing woman.
Adverse effects associated with RYNATAN®-P Pediatric Suspension 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 & 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.
Administer the recommended dose every 12 hours.
RYNATAN®-P Pediatric 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.
RYNATAN®-P Pediatric Suspension (phenylephrine tannate 5 mg, chlorpheniramine tannate 2 mg, and pyrilamine tannate 12.5 mg per 5 mL); in pint bottles (NDC 0037-0715-68).
Storage Store at controlled room temperature 20°-25°C (68°-77°F).
Dispense in a tight container.
Produced under license from
Jame Fine Chemicals, Inc.
Bound Brook, NJ, USA
Cranbury, New Jersey 08512
IN-0715-02 Rev. 1/00