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Rynatuss Tablets

Generic Name: carbetapentane tannate, chlorpheniramine tannate, ephedrine tannate, and phenylephrine tannate
Dosage Form: 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.

Rynatuss®
Tablets

 
IN-0717-16        Rev. 1/09

Description

RYNATUSS® Tablets are an antitussive/antihistamine/nasal decongestant/bronchodilator combination.

Each tablet contains:
Carbetapentane Tannate               60 mg
Chlorpheniramine Tannate               5 mg
Ephedrine Tannate                          10 mg
Phenylephrine Tannate                   10 mg

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Other ingredients: corn starch, dibasic calcium phosphate, FD&C Blue No. 1, FD&C Red No. 40, magnesium stearate, methylcellulose, polygalacturonic acid, povidone, talc.

Clinical Pharmacology

RYNATUSS® Tablets combine the antitussive action of carbetapentane, the sympathomimetic decongestant effect of phenylephrine, the antihistaminic action of chlorpheniramine, and the bronchodilator action of ephedrine.

Indications and Usage

RYNATUSS® Tablets are indicated for the symptomatic relief of cough associated with respiratory tract conditions such as the common cold, bronchial asthma, acute and chronic bronchitis. Appropriate therapy should be provided for the primary disease.

Contraindications

RYNATUSS® Tablets are contraindicated for newborns, nursing mothers, and patients who are 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. Do not use in patients taking monoamine oxidase (MAO) inhibitors, or for 14 days after stopping treatment with an MAOI.

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 RYNATUSS® Tablets.

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

Nursing mothers: RYNATUSS® 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 RYNATUSS® Tablets 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 and 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.
RYNATUSS® Tablets: Adults — 1 to 2 tablets.

How Supplied

RYNATUSS® Tablets are mauve, capsule-shaped, scored on one side and imprinted RYNATUSS 717 on the other side, containing in each tablet: carbetapentane tannate 60 mg, chlorpheniramine tannate 5 mg, ephedrine tannate 10 mg, phenylephrine tannate 10 mg, available in bottles of 100 (NDC 0037-0717-92).

Storage: 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

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. 1/09

Package Label - Principal Display Panel – 100 Tablet Bottle

NDC 0037-0717-92
100 Tablets
RYNATUSS®

(carbetapentane tannate,
chlorpheniramine tannate,
ephedrine tannate,
phenylephrine tannate)

Each tablet contains:
Carbetapentane Tannate          60 mg
Chlorpheniramine Tannate          5 mg
Ephedrine Tannate                     10 mg
Phenylephrine Tannate              10 mg
Rx Only
MEDA Pharmaceuticals™

LB-071701-09 Rev. 2/08
Usual Dosage: See package insert.
Store at controlled room temperature
20°-25°C (68°-77°F).
Protect from moisture.
Dispense in a tight container.
Tablet shade may vary among
lots; identity and purity of drug
are unaffected.

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

RYNATUSS 
carbetapentane tannate, chlorpheniramine tannate, ephedrine tannate, and phenylephrine tannate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-0717
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBETAPENTANE TANNATE (CARBETAPENTANE TANNATE) CARBETAPENTANE TANNATE 60 mg
CHLORPHENIRAMINE TANNATE (CHLORPHENIRAMINE TANNATE) CHLORPHENIRAMINE TANNATE 5 mg
EPHEDRINE TANNATE (EPHEDRINE TANNATE) EPHEDRINE TANNATE 10 mg
PHENYLEPHRINE TANNATE (PHENYLEPHRINE TANNATE) PHENYLEPHRINE TANNATE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
MAGNESIUM STEARATE  
METHYLCELLULOSE (1500 CPS)  
POVIDONE  
TALC  
POLYGALACTURONIC ACID  
Product Characteristics
Color PINK (MAUVE) Score 2 pieces
Shape CAPSULE Size 15mm
Flavor Imprint Code RYNATUSS;717
Contains         
Packaging
# Item Code Package Description
1 NDC:0037-0717-92 100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/1960 01/31/2012
Labeler - Meda Pharmaceuticals Inc. (051229602)
Revised: 06/2011
 
Meda Pharmaceuticals Inc.

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