DY-G Liquid

Signs and Symptoms:  Restlessness, anorexia, nausea, vomiting, diarrhea, insomnia, irritability, and headache are typical symptoms resulting from a xanthine drug overdose.  Marked overdosage with resulting severe vomiting, dehydration, excessive thirst, tinnitus, cardiac arrhythmias, hyperthermia, diaphoresis, and generalized clonic and tonic convulsions.  Cardiovascular collapse has also occurred, with some fatalities.  Seizures have occurred in some cases associated with very high theophylline plasma concentrations, without any premonitory symptoms of toxicity.

Treatment:  There is no specific antidote for overdosage with drugs of the xanthine class.  Symptomatic treatment and general supportive measures should be instituted with careful monitoring and maintenance of vital signs, fluids and electrolytes.  The stomach should be emptied by inducing emesis if the patient is conscious and responsive, or by gastric lavage, taking care to protect against aspiration, especially in stuporous or comatose patients.  Maintenance of an adequate airway is essential in case oxygen or assisted respiration is needed.  Sympathomimetic agents should be avoided but sedatives such as short acting barbiturates may be useful.

Dyphylline is dialyzable and although not recommended as routine procedure in overdosage cases, hemodialysis may be of some benefit with severe intoxication is present or when the patient has not responded to general supportive and symptomatic treatment.

The usual adult dose is 1 or 2 teaspoonfuls of liquid 3 or 4 times a day.  In severe cases, dosage may be doubled or tripled if necessary.  Maintenance dosage should be adjusted according to patient response.

Although pediatric dosages of dyphylline are established, no firm dosage for a combination of dyphylline and guaifenesin USP can be recommended for children under the age of six.  Dosage for children over six may be calculated on the basis of 2 to 3 mg of dyphylline per pound of body weight daily in divided doses.

The packaging below represents labeling currently label:

Principal Display Panel and Side Panel for 473 mL label:

NDC 60258-371-16

DY-G Liquid

BRONCHODILATOR/EXPECTORANT

Each teaspoonful (5mL) for oral administration contains:

Dyphylline.........................................100 mg
Guaifenesin.......................................100 mg

ALCOHOL FREE/DYE FREE/GLUTEN FREE

Rx Only

CYPRESS PHARMACEUTICAL, INC.

16 fl oz (473 mL)

DOSAGE AND ADMINISTRATION
The usual adult dose is 1 or 2 teaspoonfuls of liquid 3 or 4 times a day.
In severe cases, dosage may be doubled or tripled if necessary.
Maintenance dosage should be adjusted according to patient response.

Se attached insert for full prescribing information.

WARNING:  KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.  IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Store at controlled room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature.]

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088 (Toll Free).

Mfg. for:  Cypress Pharmaceuticals, Inc., Madison, MS 39110

L639 Rev. 05/10

DY  G dyphylline, guaifenesin liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60258-371 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 MINT Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:60258-371-16 473 mL in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/31/2001

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 06/2010   Cypress Pharmaceutical, Inc.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Fast breathing.
• Very bad dizziness or passing out.
• Seizures.
• Throwing up blood or throw up that looks like coffee grounds.
• Blood in the urine.
• Feeling irritable.
• Feeling agitated.
• Twitching.