GUAIFENESIN 600 MG TABLETS

GUAIFENESIN  - guaifenesin tablet 
Prasco Laboratories

----------

GUAIFENESIN
600 MG
TABLETS

11  DESCRIPTION

Each extended-release tablet contains:

Guaifenesin . . . . . 600 mg in a specially formulated base to provide a prolonged therapeutic effect.

Inactive ingredients: calcium phosphate, ethylcellulose, lactose monohydrate, magnesium stearate, stearic acid.

Chemically, guaifenesin is 3-(2-methoxyphenoxy)-1, 2-propanolol, and has the following structural formula:

d9bd7e08-figure-01

12  CLINICAL PHARMACOLOGY

Guaifenesin is an expectorant which increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions. By reducing the viscosity of secretions, guaifenesin increases the efficiency of the cough reflex and of ciliary action in removing accumulated secretions from the trachea and bronchi. Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour.

The major urinary metabolite is β-(2-methoxyphenoxy) lactic acid.

1  INDICATIONS & USAGE

This product is indicated for the temporary relief of coughs associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucus and/or mucus plugs and congestion. This product is effective in a productive as well as a non-productive cough which tends to injure the mucus membrane of the air passages.

4  CONTRAINDICATIONS

This product is contraindicated in patients with hypersensitivity to guaifenesin.

WARNINGS

Before prescribing medication to suppress or modify a cough, it is important that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted.

PRECAUTIONS

DRUG & OR LABORATORY TEST INTERACTIONS

Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic 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.

1  CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

No data are available on the long-term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans.

1  PREGNANCY

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

3  NURSING MOTHERS

It is not known whether guaifenesin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when guaifenesin is administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

4  PEDIATRIC USE

Appropriate studies on the relationship of age to the effects of guaifenesin have not been performed in the pediatric population. However, no pediatric-specific problems have been documented to date.

5  GERIATRIC USE

Appropriate studies on the relationship of age to the effects of guaifenesin have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

6  ADVERSE REACTIONS

No serious side effects from guaifenesin have been reported.

10  OVERDOSAGE

Overdosage with guaifenesin is unlikely to produce toxic affects since its toxicity is low. Guaifenesin, when administered by stomach tube to test animals in doses up to 5 gm/kg produced no signs of toxicity. In severe cases of overdosage, treatment should be aimed at reducing further absorption of the drug. Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion.

2  DOSAGE & ADMINISTRATION

Adults and adolescents over 12: One or two tablets every 12 hours, not to exceed 4 tablets (2400 mg) in 24 hours. Children 6 - 12: One tablet every 12 hours, not to exceed 2 tablets (1200 mg) in 24 hours. Children 2 - 6: 1/2 tablet every 12 hours, not to exceed 1 tablet (600 mg) in 24 hours.

16  HOW SUPPLIED

Supplied as white, capsule-shaped tablets, scored and debossed “320” on top, Prasco Laboratories logo on bottom. Bottles of 100 tablets, NDC 66993-320-02.

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

Dispense in tight, light-resistant containers as defined in the USP/NF.

Store at controlled room temperature 15°C - 30°C (59°F - 86°F).

Manufactured for:

PRASCO LABORATORIES

Cincinnati, OH 45249

by:

Sovereign Pharmaceuticals,

Ltd.

Fort Worth, TX 76118

PIPRAS-09

ISS. 3/2002

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

d9bd7e08-figure-02

GUAIFENESIN 
guaifenesin   tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)66993-320
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULESize10mm
FlavorImprint Code 320;PrascoLogo
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
166993-320-02100 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other12/01/201001/20/2011

Labeler - Prasco Laboratories (065969375)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, Ltd.623168267MANUFACTURE
Revised: 01/2011Prasco Laboratories