Rynatan Pediatric Suspension

Name: Rynatan Pediatric Suspension

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.

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.

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.

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.

Rx 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.
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