Name: Jay Phyl
drugs can cause excessive CNS stimulation. Such combinations are contraindicated in children unless
accompanied by sufficient sedation to prevent undue CNS stimulation.
Use caution when administering to children six years of age or older.
Postprandial administration may help avoid gastric discomfort.
The following adverse reactions which have been reported with other xanthine bronchodilators,
and which have most often been related to excessive drug plasma levels, should be considered
as potential adverse effects when dyphylline is administered.
Gastrointestinal: nausea, vomiting, epigastric pain, hematemesis, diarrhea.
Central Nervous System: headache, irritability, restlessness, insomnia, hyperexcitability,
agitation, muscle twitching, generalized clonic and tonic convulsions.
Cardiovascular: palpitation, tachycardia, extrasystoles, flushing, hypotension, circulatory failure,
Renal: albuminuria, gross and microscopic hematuria, diuresis.
Other: hyperglycemia, inappropriate ADH syndrome.
Large doses of Guaifenesin may produce emesis, but gastrointestinal upset at ordinary dosage
levels is rare.
Principal Display Panel and Side Panel for 15 mL Label:
Each 5 mL contains:
Dyphylline............. 100 mg
Guaifenesin........... 50 mg
Sugar and Alcohol Free
1/2 fl oz (15 mL)
DOSAGE AND ADMINISTRATION:
Adults: 2 teaspoonfuls (10 mL) 3 or 4 times daily. Children 6 to 12 should be started on low doses
which are gradually increased to the lowest effective dose, not to exceed 10mg/kg/day in divided
doses. Not recommended for pediatric patients under 6 years.
See package insert for full prescribing information.
Store at controlled room temperature, 15o-30oC (59o-86oF).
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSE, CONTACT A POISON CONTROL
CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.
Sunset, LA 70584 Rev. 11/07
NOT FOR RESALE
dyphylline and guaifenesin syrup
|Labeler - JayMac Pharmaceuticals LLC (830767260)|
|Registrant - Great Southern Laboratories (056139553)|
|Great Southern Laboratories||056139553||manufacture|
What is the most important information I should know about Jay-Phyl (dyphylline and guaifenesin)?
Dyphylline and guaifenesin should not be given to a child younger than 6 years old.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include agitation, vomiting, extreme thirst, ringing in your ears, sweating, feeling hot, slow or irregular heart rate, or seizure (convulsions).
Jay-Phyl (dyphylline and guaifenesin) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
pounding heartbeats or fluttering in your chest;
rapid breathing, feeling short of breath;
seizure (convulsions); or
coughing up blood or vomit that looks like coffee grounds.
Common side effects may include:
nausea, vomiting, stomach pain, diarrhea;
feeling restless or irritable;
sleep problems (insomnia); or
flushing (warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For the Consumer
Applies to dyphylline / guaifenesin: oral liquid