Jay Phyl

As with other theophylline-type drugs, combining dyphylline with epehdrine or other sympathomimetic
drugs can cause excessive CNS stimulation. Such combinations are contraindicated in children unless
accompanied by sufficient sedation to prevent undue CNS stimulation.

Safety and effectiveness in children below the age of six have not been established.
Use caution when administering to children six years of age or older.

This formulation may cause nausea, headache, cardiac palpitation and CNS stimulation.

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,
ventricular arrhythmias.

Respiratory: tachypnea.

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.

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 15 mL Label:

NDC 64661-814-15

Jay-Phyl Syrup

Each 5 mL contains:
Dyphylline............. 100 mg
Guaifenesin........... 50 mg

Sugar and Alcohol Free

Rx Only

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.

Manufactured for:
JayMac Pharmaceuticals
Sunset, LA 70584                 Rev. 11/07

PROFESSIONAL SAMPLE
NOT FOR RESALE

JAY-PHYL  dyphylline and guaifenesin syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64661-814 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dyphylline (Dyphylline) Dyphylline 100 mg  in 5 mL Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL

Product Characteristics Color      Score      Shape Size Flavor VANILLA Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:64661-814-15 15 mL in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/02/2006

Labeler - JayMac Pharmaceuticals LLC (830767260)

Registrant - Great Southern Laboratories (056139553)

Establishment
Name	Address	ID/FEI	Operations
Great Southern Laboratories		056139553	manufacture

Revised: 12/2009   JayMac Pharmaceuticals LLC

Dyphylline and guaifenesin should not be given to a child younger than 6 years old.

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).

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;

• headache;

• 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.

Applies to dyphylline / guaifenesin: oral liquid