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Expectuss Liquid

Generic Name: carbetapentane citrate, and guaifenesin
Dosage Form: liquid

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.

Expectuss Liquid

Description:

Expectuss Liquid is an alcohol-free, sugar-free, purple liquid for oral administration having a grape odor and flavor.

Each Teaspoon (5 mL) Contains:

CARBETAPENTANE CITRATE 20 mg
GUAIFENESIN 75 mg

CLINICAL PHARMACOLOGY:

Carbetapentane citrate is a centrally acting non-narcotic antitussive.

Guaifenesin is an expectorant. Its action increases the output of respiratory tract fluid by reducing
adhesiveness and surface tension. Sinus and bronchial drainage is improved and dry, nonproductive
coughs become more productive and less frequent.

INDICATIONS AND USAGE:

For temporary relief of non-productive cough accompanying respiratory tract congestion associated with
the common cold, influenza, sinusitis, and bronchitis.

CONTRAINDICATIONS:

Expectuss Liquid is contraindicated in infants, newborns, and in patients with a known
hypersensitivity to any of the components. It is also contraindicated in patients on MAO inhibitor therapy.

WARNINGS:

A persistent cough may be a sign of a serious condition. If cough persists for more than one week
or tends to recur, or is accompanied by fever, rash, or persistent headache, patient reevaluation
should be considered.

PRECAUTIONS: DRUG INTERACTIONS:

Guaifenesin may produce an increase in urinary 5-hydroxy-indoleacetic acid and may therefore interfere
with the interpretation of this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the
 VMA test for catechols. Administration of this drug should be discontinued 48 hours prior to the collection
of urine specimens for such tests.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY:

No adequate and well controlled studies have been conducted to determine whether the components
of Expectuss Liquid have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

PREGNANCY:

Pregnancy Category C: Animal reproduction studies have not yet been conducted with this product.
It is not known whether it can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. This product should not be administered to pregnant women.

NURSING MOTHERS:

Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.

ADVERSE REACTIONS:

Guaifenesin is well tolerated and has a wide margin of safety. Side effects are generally
mild and infrequent. Nausea and vomiting are the most common side effects. Dizziness,
headache, and rash (including urticaria) have been reported rarely.

OVERDOSAGE: SIGNS AND SYMPTOMS:

Incidence of acute toxicity with guaifenesin is low and over dosage is unlikely to produce
serious toxic effects. In laboratory animals no toxicity resulted when guaifenesin was
administered by stomach tube in doses up to 5 grams/kg.

TREATMENT: Treatment of the signs and symptoms of overdosage is symptomatic and
supportive. The patient should be induced to vomit, even if emesis has occurred spontaneously.
Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however,
vomiting should not be induced in patients with impaired consciousness. Precautions against
aspiration must be taken, especially in infants and children. Following emesis, any drug
remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water.

DOSAGE AND ADMINISTRATION:

Expectuss Liquid is administered orally as follows:

Adults: 1-2 teaspoonfuls every 4-6 hours or as directed by a physician.
Children 6-12 years of age: 1 teaspoonful every 4-6 hours or as directed by a physician.
Children 6 years of age and under: as directed by a physician.


How supplied:

16 fluid ounce bottles NDC# 23359-003-16

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

Store between 59o-86oF (15o-30oC).

DISPENSE IN TIGHT, LIGHT RESISTANT CONTAINERS WITH CHILD RESISTANT CLOSURES
AS DEFINED IN THE USP/NF.

Manufactured for:

Centurion Labs, LLC.
Birmingham, AL 35243

For Professional Use
Consult a Physician

Rev. 7/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

NDC 23359-003-16

Expectuss Liquid

ANTITUSSIVE/EXPECTORANT

Each 5 mL (1 teaspoon) contains:
Carbetapentane Citrate..... 20 mg
Guaifenesin...................... 75 mg

SUGAR FREE
ALCOHOL FREE

Rx Only

1 PINT (473 mL)

CENTURION LABS



Side Panels:

USUAL DOSAGE:

Adults:
1-2 teaspoonfuls every 4 to 6 hours or as directed by a physician.

Children 6-12 years of age:
1 teaspoonful every 4 to 6 hours or as directed by a physician.

Children 2-6 years of age:
1/2 teaspoonful every 4-6 hours or as directed by a physician.

Children under 2 years of age:
Use as directed by a physician.

See package insert for complete prescribing information.

PHARMACIST:
Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

This container is not intended for dispensing to the patient.

DO NOT USE IF FOIL SEAL IS BROKEN OR MISSING!


INDICATIONS AND USAGE:
For temporary relief of non-productive cough accompanying respiratory tract congestion associated
with the common cold, influenza, sinusitis, and bronchitis.

STORAGE:
Store at controlled room temperature, 59o-86oF (15o-30oC).

Keep this and all drugs out of the reach of children.

In case of accidental overdosage, contact a poison control center and seek professional
assistance immediately.


Manufactured For:
Centurion Labs, LLC.
Birmingham, AL 35243

Rev. 07/07


EXPECTUSS  LIQUID
carbetapentane citrate, and guaifenesin liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:23359-003
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbetapentane Citrate (Carbetapentane) Carbetapentane Citrate 20 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 75 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:23359-003-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/30/2009
Labeler - Centurion Labs, LLC (806756461)
Revised: 12/2009
 
Centurion Labs, LLC



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