maximum of 600 mg/day;
(6-12 yr) 100-200 mg q
125mg/mL Oral
Product
SolutionDescription:
Expectorant
Formulation:
Guaifenesin
Pharmacodynamics
Through to act as an
expectorant by irritating
the gastric mucosa and
stimulating respiratory
tract secretions, thereby
increasing respiratory fluid
volumes and decreasing
phlegm viscosity.
Absorption: Well absorbed
Half-life elimination:
~1hour
Pharmacokinetics
Well absorbed from the GI
tract. Metabolized in the
liver. Excreted in urine
Indications: Temporary
relief of cough associated
with respiratory tract
infections and related
conditions such as sinusitis,
pharyngitis, bronchitis, and
asthma when these
conditions are complicated
by tenacious mucus or
nonproductive cough; helps
loosen phlegm and thin
bronchial secretions in
patients with stable chronic
bronchitis.
Dosage and
Administration:
Adult dosage. PO as an
expectorant 100-400 mg
q4hr; SR 600-1200 mg q 12
hr, to a maximum of
2.4g/day
Pediatric Dosage. PO as
an expectorant (2-6 yr)
50-100 mg q 4 hr, to a
years: 12 mg/kg/day; 2-5
years: 600 mg/day; 6-11
4hr, to a maximum of 1200
mg/day; (12 yr) same as > 12 years and Adults: 2.4
adult dosage. SR (2-6 yr)
300 mg q 12 hr; (6-12yr)
600 mg q 12 hr.
Contraindications:
Hypersensitivity to
guaifenesin or any
component of the
formulation
Warnings/Precautions:
Not for persistent cough
such as occurs with
smoking, asthma, or
emphysema or cough
accompanied by excessive
secretions
Pregnancy
Consideration
Based on the limited
available data, an
increased risk of adverse
birth outcomes has not
been observed following
maternal use of
guaifenesin in pregnancy.
Alcohol may be
present in some liquid
formulations of
guaifenesin. If
consumed in sufficient
quantities during
pregnancy, fetal alcohol
syndrome may result.
Guaifenesin has been
investigated as an agent to
improve cervical mucus
and improve fertility.
Lactation: Excretion in
breast milk unknown/use
caution
Interactions: Drug: None
known
Herbal: None known
Food: None known
Adverse Effects: Rare
Dizziness, headache, rash,
diarrhea, nausea, vomiting,
abdominal pain.
Overdosage and
Treatment: Limit Dose: <2
years: 1.2 g/day; Children
g/day
Overdosage: Symptoms
include vomiting, lethargy,
coma, and respiratory
depression. Treatment is
supportive.
Storage Conditions:
Store syrup, liquid, and
capsules at room
temperature(59 to 86)
Dosage Forms and
Packaging Available:
Cap: 200 mg; Syrup: 20, 40
mg/mL; Tab: 100, 200,
1200 mg; SR Cap: 300 mg;
SR Tab: 600, 1200 mg; SR
Tab: 600 mg with
pseudoephedrine 120 mg
(Entex PSE, various)
Name and Address of
Marketing Authorization
Holder:
UST Laboratories
Espaa, Manila
Zalupex Pharmaceuticals
Villa Corazon, Barangay Del
Rosario, Naga City
ADR Reporting
Statement:
For suspected adverse
drug reaction, report to
the FDA:
www.fda.gov.ph
Registration Number:
DR#XYZ Prep No. 1
Date of First
Authorization/Renewal
of the Authorization:
09/02/17
Date of Revision of
Package Insert: 09/02/17