Phenylephrine, Carbetapentane, Potassium Guaiacolsulfonate

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:



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:



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

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

General: Use with caution in patients with severe impairment of liver or kidney function, hypothyroidism, thyroid diseases, Addison’s diseases, hypertension, heart disease, asthma, increased intraocular pressure, diabetes mellitus, and prostatic hypertrophy or urethral stricture. Narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions or head injuries.

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

Drug interactions:
MAO inhibitors prolong and intensify the anticholinergic effects of reserpine, veratrum alkaloids, methyldopa, and mecamylamine. Effects of sympathomimetics are increased with MAO inhibitors and beta adrenergic blockers.

Carcinogenesis, Mutagenesis, Impairment of Fertility:
Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with this product. It is also not known whether this medication can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Phenylephrine 10 mg/Carbetapentane 20 mg/Potassium Guaiacolsulfonate 100 mg/5 mL should be given to a pregnant woman only if clearly needed.

Labor and Delivery:
Administration of phenylephrine to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.

Nursing Mothers:
Some sympathomimetics are excreted in breast milk. Use of this product by nursing mothers is not recommended.

Geriatric Use:
The elderly are more likely to experience adverse reactions to sympathomimetics. An overdose of sympathomimetics in this age group may cause hallucinations, convulsions, CNS, depression, and death.

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

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

PHENYLEPHRINE CARBETAPENTANE POTASSIUM GUAIACOLSULFONATE  Phenylephrine, Carbetapentane, Potassium Guaiacolsulfonate liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: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 # Item Code Package Description 1 NDC:68032-490-16 473 mL in 1 BOTTLE

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