PHENYLEPHRINE CARBETAPENTANE POTASSIUM GUAIACOLSULFONATE  - phenylephrine, carbetapentane and potassium guaiacolsulfonate liquid 
River's Edge Pharmaceuticals, LLC

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Phenylephrine 10 mg/Carbetapentane 20 mg/Potassium Guaiacolsulfonate 100 mg/5 mL

DESCRIPTION

Phenylephrine 10 mg/Carbetapentane 20 mg/Potassium Guaiacolsulfonate 100 mg/5 mL is an alcohol free, dye free, sugar free, clear and colorless liquid with a raspberry mint scent and flavor.
Each 5mL (1 teaspoonful) for oral administration contains:
Phenylephrine hydrochloride ........................10 mg
Carbetapentane citrate ................................ 20 mg
Potassium guaiacolsulfonate ........................100 mg
Inactive ingredients: sodium citrate, citric acid, sodium saccharin, sorbitol, glycerin, propylene glycol, deionized water, menthol mint and raspberry flavor.

Phenylephrine hydrochloride is an orally effective nasal decongestant having the chemical name, benzenemethanol, 3-hydroxy-α−[(methylamino)methyl]-hydrochloride, an adrenergic which occurs as white or practically white, odorless crystals, having a bitter taste. It is freely soluble in water and in alcohol. The structural formula is:

structure1

Carbetapentane citrate or, 1-Phenylcyclopentane-carboxylic acid, 2-(2-diethylaminoethoxy) ethyl ester citrate, is a white crystalline powder. It is freely soluble in water and chloroform. Its structure is as follows:

structure2

Chemically, potassium guaiacolsulfonate is benzene-sulfonic acid, hydroxy-methoxy-, monopotassium salt, hemihydrate with the following structure:

structure3

CLINICAL PHARMACOLOGY

Phenylephrine HCI:


Carbetapentane citrate:



Potassium guaiacolsulfonate:

INDICATIONS AND USAGE

For temporary relief of nonproductive cough, nasal congestion, and other upper respiratory symptoms associated with allergy, influenza, sinusitis bronchitis, or the common cold.

CONTRAINDICATIONS

Patients with hypersensitivity to any of the listed ingredients, patients taking monoamine oxidase (MAO) inhibitors, patients with narrow-angle glaucoma, urinary retention, peptic ulcer, severe hypertension or coronary artery disease or intracranial lesion associated with increased intracranial pressure, or patients undergoing an asthmatic attack.

WARNINGS




KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

PRECAUTIONS

General:

Information for Patients:
DO NOT EXCEED RECOMMENDED DOSES.  DISCONTINUE USE IF ADVERSE REACTION(S) OCCUR. 


Drug interactions:


Carcinogenesis, Mutagenesis, Impairment of Fertility:
Teratogenic Effects:
Phenylephrine 10 mg/Carbetapentane 20 mg/Potassium Guaiacolsulfonate 100 mg/5 mL

Labor and Delivery:


Nursing Mothers:


Geriatric Use:

ADVERSE REACTIONS


To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Phenylephrine 10 mg/Carbetapentane 20 mg/Potassium Guaiacolsulfonate 100 mg/5 mL

Signs and Symptoms:


Treatment:









DOSAGE AND ADMINISTRATION

Phenylephrine 10 mg/Carbetapentane 20 mg/Potassium Guaiacolsulfonate 100 mg/5 mL is administered orally as follows:
ADULTS: 1-2 teaspoonfuls every 4-6 hours or as directed by a physician.
CHILDREN 6 to 12 years of age: 1 teaspoonful every 4-6 hours or as directed by a physician.

HOW SUPPLIED

Phenylephrine 10 mg/Carbetapentane 20 mg/Potassium Guaiacolsulfonate 100 mg/5 mL is an alcohol free, dye free, sugar free, clear and colorless liquid with a raspberry mint scent and flavor supplied in 16 oz (473 mL) bottles, NDC 68032-490-16.

Store at controlled room temperature between 15°-30°C (59°-86°F).
PHARMACIST: Dispense in a tight, light resistant container with a child resistant closure as described in the USP/NF.
TAMPER EVIDENT BY HEAT SEAL UNDER CAP. DO NOT USE IF THERE IS EVIDENCE OF TAMPERING.

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Rx Only
Iss. 2/10     490-10

PACKAGING

Below represents the current packaging being used:

NDC 68032-490-16
Phenylephrine 10 mg/Carbetapentane 20 mg/Potassium Guaiacolsulfonate 100 mg/5 mL
Decongestant • Antitussive • Expectorant

One Pint (473 mL)

DOSAGE AND ADMINISTRATION:
ADULTS:
1-2 teaspoonfuls every 4-6 hours or as directed by a physician.
CHILDREN 6 to 12 years of age: 1 teaspoonful every 4-6 hours or as directed by a physician.

Refer to package insert for full prescribing information.

DISPENSE:
In a tight, light resistant container with a child resistant closure as described in the USP/NF.

STORE AT CONTROLLED ROOM TEMPERATURE BETWEEN 15°-30°C (59°-86°F).

TAMPER EVIDENT BY HEAT SEAL UNDER CAP. DO NOT USE IF THERE IS EVIDENCE OF TAMPERING.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSE, CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.


Manufactured for:
River’s Edge Pharmaceuticals, LLC.
Suwanee, GA 30024

Rx Only
Iss. 2/10
490-20

label

PHENYLEPHRINE CARBETAPENTANE POTASSIUM GUAIACOLSULFONATE 
phenylephrine, carbetapentane, potassium guaiacolsulfonate   liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-490
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE (PHENYLEPHRINE) PHENYLEPHRINE 10 mg  in 5 mL
CARBETAPENTANE (CARBETAPENTANE) CARBETAPENTANE 20 mg  in 5 mL
POTASSIUM GUAIACOLSULFONATE (POTASSIUM CATION) POTASSIUM GUAIACOLSULFONATE 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE  
CITRIC ACID MONOHYDRATE  
SACCHARIN SODIUM  
SORBITOL  
GLYCERIN  
PROPYLENE GLYCOL  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor RASPBERRY (Raspberry-Mint) Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 68032-490-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2010

Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 02/2010 River's Edge Pharmaceuticals, LLC