EndaCof-C

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

EndaCof-C Liquid is a sugar free, alcohol free, dye free, gluten free, cotton candy flavored antitussive/antihistamine available for oral administration.

Each teaspoonful (5 mL) contains:

Codeine Phosphate   ………..…….  10 mg
(WARNING: May be habit forming)

Chlorpheniramine Maleate  ….... 2 mg

Codeine Phosphate is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is affected by light. Its chemical name is: 7,8-Didehydro-4,5-(-epoxy-3-methoxy-17-methylmorphinan<-6-(-ol phosphate (1:1) (salt) hemihydrate. Its structure is as follows:

Figure 1

C18H21NO3 • H3PO4 • ½ H2O                  M.W. 406.37

Chlorpheniramine Maleate is an antihistamine having the chemical name: 2-Pyridinepropanamine, γ-(4-chlorphenyl) -N,N-dimethyl-, (Z)-2-butenedioate (1:1). , and has the following chemical formula:

Figure 2

C16H19ClN2 • C4H4O4                           M.W. 390.86

Inactive Ingredients: Propylene glycol, Sorbitol, Citric acid, Sodium benzoate, Saccharin sodium, Cotton candy flavor, Purified Water.

May cause excitability especially in children. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor. May cause or aggravate constipation.

Use caution when giving to children or patients with chronic pulmonary disease, shortness of breath, difficulty inbreathing, asthma, emphysema, high blood pressure, heart disease, diabetes, thyroid disease, or difficulty in urination due to enlargement of the prostate gland unless directed by a physician. Antihistamines may cause hyper excitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling.

The most frequent adverse reactions to EndaCof-C Liquid include sedation; dryness of mouth, nose, and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extra systoles. Dermatologic: Urticaria, drug rash, photosensitivity, and pruritus.

Central Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.

Gastrointestinal: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.

Genitourinary: Urinary frequency, difficult urination, urinary retention, early menses.

Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

Applies to chlorpheniramine / codeine: oral suspension extended release

Along with its needed effects, chlorpheniramine / codeine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking chlorpheniramine / codeine:

• Acid or sour stomach
• anxiety
• belching
• bloating
• blurred or loss of vision
• chills
• cold clammy skin
• cold sweats
• confusion
• dark colored urine
• depression
• diarrhea
• difficult or painful urination
• disturbed color perception
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• dryness or spasm of the throat
• feeling of constant movement of self or surroundings
• fever
• halos around lights
• headache
• heartburn
• increased hunger
• indigestion
• irregular, fast or slow, or shallow breathing
• loss of appetite
• nausea
• nervousness
• night blindness
• nightmares
• overbright appearance of lights
• pain in the stomach, side, or abdomen, possibly radiating to the back
• pain or discomfort in the chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• pressure in the stomach
• pounding in the ears
• seizures
• sensation of spinning
• shakiness
• sleepiness or unusual drowsiness
• slow, fast, or irregular heartbeat
• slurred speech
• stomach discomfort, upset, or pain
• sweating
• tunnel vision
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Some side effects of chlorpheniramine / codeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Anxiety
• blistering, crusting, or irritation of the skin
• continuing ringing or buzzing or other unexplained noise in the ears
• cracked, dry, scaly skin
• dry mouth
• early menstrual periods
• face is warm or hot to touch
• false or unusual sense of well-being
• general feeling of discomfort or illness
• hearing loss
• hiccups
• increased appetite
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• irritability
• lack or loss of strength
• redness of the face
• restlessness
• skin rash, itching, redness, hives, swelling
• swelling of the breasts or breast soreness in both females and males
• trouble sleeping
• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• watering of eyes