sincerely Rynatan Pediatric Suspension Generic Name: phenylephrine tannate and chlorpheniramine tannate Dosage Form: oral suspension Side Effects Dosage Professional Interactions Pregnancy More User Reviews Drug Images Support Group Q & A 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. REFORMULATED RYNATAN Pediatric Suspension IN-0714-07 Rev. 1/09 Description Rynatan Pediatric Suspension is an antihistamine/nasal decongestant combination available for oral administration as a Suspension . Each 5 mL (one teaspoonful) of the slate-purple-colored, natural strawberry- artificial currant flavored Suspension contains: Phenylephrine Tannate 5 mg Chlorpheniramine Tannate 4.5 mg Other ingredients: benzoic acid, FD&C Blue No.1, FD&C Red No. 3, FD&C Red No. 40, FD&C Yellow No. 5 (see Precautions ), flavors (natural and artificial), glycerin, kaolin, magnesium aluminum silicate, methylparaben, pectin, purified water, saccharin sodium, sucrose. Slideshow Over the Counter Cold Remedies - Which One is Right For You? Clinical Pharmacology Rynatan Pediatric Suspension combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of chlorpheniramine. Indications and Usage Rynatan 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. Contraindications Rynatan Pediatric Suspension 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. 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 This product contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. 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 Pediatric Suspension. Pregnancy: Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Rynatan Pediatric Suspension. It is also not known whether Rynatan Pediatric Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Rynatan Pediatric Suspension should be given to a pregnant woman only if clearly needed. Nursing mothers: Rynatan Pediatric Suspension 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 Rynatan 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. 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 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. How Supplied Rynatan Pediatric Suspension (phenylephrine tannate 5 mg, and chlorpheniramine tannate 4.5 mg per 5 mL) in pint bottles (NDC 0037-0714-16). Storage: Store at controlled room temperature 20 -25 C (68 -77 F). 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. Patents 6,037,358; 5,663,415; 5,599,846 Produced under license from JFC Technologies Bound Brook, NJ, U.S.A. MEDA Pharmaceuticals Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 Printed in U.S.A. Rev. 1/09 Package Label - Principal Display Panel 473 mL (One Pint) Bottle NDC 0037-0714-16 One Pint (473 mL) REFORMULATED RYNATAN Pediatric Suspension Each 5 mL (one teaspoonful) contains: Phenylephrine Tannate 5 mg Chlorpheniramine Tannate 4.5 mg Other ingredients: benzoic acid, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40, FD&C Yellow No. 5 (see Precautions ), flavors (natural and artificial), glycerin, kaolin, magnesium aluminum silicate, methylparaben, pectin, purified water, saccharin sodium, sucrose. R x Only SHAKE WELL MEDA Pharmaceuticals Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 REFORMULATED RYNATAN PEDIATRIC phenylephrine tannate and chlorpheniramine tannate suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-0714 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE TANNATE (PHENYLEPHRINE) PHENYLEPHRINE TANNATE 5 mg in 5 mL CHLORPHENIRAMINE TANNATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE TANNATE 4.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 FD&C RED NO. 3 FD&C RED NO. 40 FD&C YELLOW NO. 5 GLYCERIN KAOLIN METHYLPARABEN PECTIN WATER SACCHARIN SODIUM SUCROSE BENZOIC ACID Product Characteristics Color PURPLE Score Shape Size Flavor STRAWBERRY (Strawberry currant) Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0037-0714-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/15/2001 03/31/2012 Labeler - Meda Pharmaceuticals Inc. (051229602) Revised: 06/2011 Meda Pharmaceuticals Inc. Next Interactions Print this page Add to My Med List More about Rynatan Pediatric (chlorpheniramine / phenylephrine) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: upper respiratory combinations Consumer resources Professional resources Rynatan Chewable Pediatric Tablets (FDA) Other brands: AccuHist Drops , R-Tanna , Sildec-PE , Sonahist Other Formulations Rynatan Related treatment guides Allergic Rhinitis Cold Symptoms} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug WADA Class Anti-Doping Classification Drug Class Upper respiratory combinations Related Drugs upper respiratory combinations Promethazine DM , Cheratussin AC , Mucinex DM Cold Symptoms diphenhydramine , Benadryl , Promethazine DM , chlorpheniramine , echinacea , Tussionex Pennkinetic , Banophen , Benadryl Allergy , Chlor-Trimeton , Guaifenex , Triaminic , Promethazine with Dextromethorphan , More... Allergic Rhinitis prednisone , Zyrtec , promethazine , fluticasone nasal , loratadine , cetirizine , Flonase , triamcinolone nasal , montelukast , Claritin , Singulair , More... Rynatan Pediatric Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Rynatan Pediatric Images Rynatan Pediatric 4.5 mg / 5 mg (RYNATAN 712 ) View larger images} } new version
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