Each long-acting, film-coated, dye
free Guaifenex® Gy Tablet
Also contains: Microcrystalline cellulose, magnesium
stearate and other
ingredients. Film coating composed of hydroxypropyl methylcellulose,
maltodextrin and polyethylene
Guaifenesin is an expectorant. Chemically, it is 3-(2-methoxyphenoxy)-1,2
Guaifenex® Gy Tablets
help loosen phlegm (mucus)
and thin bronchial secretions. The result is enhanced wflow
of less viscid secretions
to lubricate irritated mucous
membranes and increase the efficiency of the mucocilliary mechanism
in removing accumulated secretions from the upper and lower airway.
As a result, sinus and
is improved and nonproductive coughs become more productive. Guaifenex®
Gy Tablets are indicated
for the temporary relief
of symptoms associated with respiratory tract
infections and related conditions such as sinusitis, pharyngitis,
bronchitis, and allergies, when these conditions are complicated
by tenacious mucus
and/or mucus plugs and excess secretions.
DOSAGE AND ADMINISTRATION
Adults and pediatric
patients over 12 years of age: One tablet every 12 hours, not
to exceed 2 tablets (2400 mg) in 24 hours.
Pediatric patients 6 to 12 years of age: One-half (1/2)
tablet every 12 hours not to exceed 1 tablet
(1200 mg) in 24 hours. Tablets may be broken in half (but not crushed
or chewed) without affecting the release of the medication.
Guaifenex® Gy Tablets
(guaifenesin 1200 mg) are supplied as white, dye free, film
coated, capsule shaped
tablets debossed ETHEX/ 308 right side of bisect, in bottles
of 100 tablets (NDC 58177-308-04).
Store at controlled room
30° C (59°- 86° F).
Dispense in tight container
with child- resistant closure.
Protect from light and
CAUTION: Federal wlaw
prohibits dispensing without prescription.
Guaifenesin is an expectorant. Expectorants promote and facilitate
the removal of respiratory tract
secretions by increasing sputum
volume and making sputum
less viscous. 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 beta-(2-methoxyphenoxy) lactic acid.
Guaifenesin is well tolerated and has a wide margin
of safety. Side effects are generally mild and infrequent. Nausea
and vomiting are the
most frequently occurring side
effects. Dizziness, headache
and rash (including urticaria)
have been reported rarely.
Laboratory Test Interactions: Guaifenesin interferes with
the calorimetric determination
of 5-HIAA (5-hydroxyindoleacetic
acid) and VMA (vanillylmandelic acid).
No information provided.
TO PRESERVE THE LONG-ACTING EFFECT, DO NOT CRUSH OR
CHEW TABLETS BEFORE INGESTION.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No data are available on the long term
potential of guaifenesin
for carcinogenesis, mutagenesis
or impairment of
fertility in animals or humans.
Teratogenic Effects: Pregnancy Category C. Animal
reproduction studies have not been conducted with guaifenesin. Safe
use in pregnancy has not been established relative to possible adverse
effects on fetal development. Therefore, this product
should not be used in pregnant
patients, unless in the judgement of the physician, the potential
benefits outweigh possible hazards.
It is not known whether guaifenesin
is excreted in human milk.
Because many drugs are excreted in human
milk, caution should be exercised when these products are administered
to a nursing mother
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.
Safety and effectiveness
in pediatric patients
under 6 years has not been established.
Laboratory Test Interactions
G uaifenesin interferes with the calorimetric determination
of 5-HIAA (5-hydroxyindoleacetic acid) and VMA
Overdosage with guaifenesin
is unlikely to produce serious toxic
effects due to its wide margin
of safety. When laboratory animals were administered guaifenesin
in doses up to 5 grams/kg by stomach
tube, no toxicity resulted. In severe cases of overdosage, the stomach
should be emptied (emesis or gastric lavage) and further absorption
prevented. Treatment should be directed toward supporting the patient
and reversing the effects of the drugs.
Guaifenex® Gy Tablets
are contraindicated in patients hypersensitive to any of the ingredients.