A white opaque and clear capsule containing white beads.
Each capsule contains:
Pseudoephedrine hydrochloride ........................... 120 mg
in a specially prepared base to provide prolonged action.
Guaifenesin ......................................................... 250 mg
designed for immediate release to provide rapid action.
A blue and clear capsule containing white beads.
Each capsule contains:
Pseudoephedrine hydrochloride ............................. 60 mg
in a specially prepared base to provide prolonged action.
Guaifenesin ......................................................... 300 mg
designed for immediate release to provide rapid action.
GUAIFED® AND GUAIFED-PD® CAPSULES also contain as inactive ingredients: Calcium Stearate, FD&C Blue #1 (Guaifed-PD® only), Gelatin, Pharmaceutical Glaze, Starch, Sucrose, Talc, and Titanium Dioxide.
GUAIFED® and GUAIFED-PD® contain ingredients of the following therapeutic classes: nasal decongestant and expectorant.
Pseudoephedrine hydrochloride is a sympathomimetic which acts predominantly on alpha adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction and has little action on beta receptors. It therefore functions as an oral nasal decongestant with minimal central nervous system (CNS) stimulation. Pseudoephedrine hydrochloride also increases sinus drainage and secretions. Guaifenesin is an expectorant which increases the output of phlegm (sputum) and bronchial secretions by reducing adhesiveness and surface tension. The increased flow of less viscid secretions promotes ciliary action and changes a dry, unproductive cough to one that is more productive and less frequent.
For temporary relief of nasal congestion and dry non-productive cough associated with the common cold and other respiratory allergies. Helps drainage of the bronchial tubes by thinning the mucus.
This product is contraindicated in patients with a known hypersensitivity to any of its ingredients. Also contraindicated in patients with severe hypertension, severe coronary artery disease and patients on Monoamine Oxidase (MAO) inhibitor therapy. Should not be used during pregnancy or in nursing mothers.
Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. The elderly (60 years or older) are more likely to exhibit adverse reactions. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur.
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or where cough is accompanied by excessive secretions except under the advice and supervision of a physician. This medication should be taken a few hours prior to bedtime to minimize the possibility of sleeplessness. Take this medication with a glass of water after each dose, to help loosen mucus in the lungs.
General: Caution should be exercised in patients with high blood pressure, heart disease, diabetes or thyroid disease and in patients who exhibit difficulty in urination due to enlargement of the prostate gland. Check with a physician if symptoms do not improve within 7 days or if accompanied by high fever, rash or persistent headache.
Drug Interactions: Do not take this product if you are presently taking a prescription drug for high blood pressure or depression, without first consulting a physician. MAO inhibitors and beta adrenergic blockers may increase the effect of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Pseudoephedrine hydrochloride may increase the possibility of cardiac arrhythmias in patients taking digitalis glycosides.
It has been shown that pseudoephedrine hydrochloride can cause reduced average weight, length, and rate of skeletal ossification in the animal fetus.
Nursing Mothers: Pseudoephedrine is excreted in breast milk; use by nursing mothers is not recommended because of the higher than usual risk of side effects from sympathomimetic amines for infants, especially newborn and premature infants.
Geriatrics Pseudoephedrine should be used with caution in the elderly because they may be more sensitive to the effects of the sympathomimetics.
Adverse reactions include nausea, cardiac palpitations, increased irritability or excitement, headache, dizziness, tachycardia, diarrhea, drowsiness, stomach pain, seizures, slowed heart rate, shortness of breath and/or troubled breathing.
Pediatric Use: Safety and effectiveness in pediatric patients less than 6 years of age has not been established for GUAIFED-PD® , and safety and effectiveness in pediatric patients less than 12 years of age has not been established for GUAIFED® . See Contraindications , , and Precautions for complete information.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF SUSPECTED OVERDOSE, IMMEDIATELY CALL YOUR REGIONAL POISON CONTROL CENTER AND/OR SEEK PROFESSIONAL ASSISTANCE.
Symptoms of overdosage may be caused by pseudoephedrine. Symptoms of overdosage with pseudoephedrine include anxiety, tenseness, respiratory difficulty, headache and awareness of the slow forceful heartbeat.
Treatment of Overdose: The stomach should be emptied promptly by emetics and/or gastric lavage. The installation of activated charcoal also should be considered. Cardiac function and serum electrolytes should be monitored and treatment instigated if indicated. If convulsions or marked CNS excitement occurs, diazepam may be used.
Adults and pediatric patients 12 years of age and over: 1 capsule every 12 hours.
Pediatric patients 6 to under 12 years of age: 1 capsule every 12 hours. Adults and pediatric patients 12 years of age and over: 1-2 capsules every 12 hours.
Bottles of 100
(NDC 0451-4002-50).
Bottles of 500
(NDC 0451-4002-60).
Each capsule is coded "GUAIFED" "MURO 120-250."
Bottles of 100
(NDC 0451-4003-50).
Bottles of 500
(NDC 0451-4003-60).
Each capsule is coded "GUAIFED-PD" "MURO 60-300."
Dispense in tight, child-resistant containers as defined in USP/NF.
Store at controlled room temperature between 15°-30°C (59°-86°F).
Keep this and all drugs out of reach of children.
Dist. by:
MURO
Pharmaceutical, Inc.
an ASTA Medica company
Tewksbury, MA 01876-1496
Mfd. by:
PharmaFab
Grand Prairie, TX 75050
I-4003-12
PIN040401 11/99