Medication Guide App

Pseudoephedrine and Codeine Syrup

Generic Name: codeine phosphate and pseudoephedrine hydrochloride
Dosage Form: syrup

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Pseudoephedrine &
Codeine Liquid

CV

Rx Only

Antitussive • Decongestant
Sugar free • Alcohol free • Dye free

Pseudoephedrine and Codeine Syrup Description

Pseudoephedrine & Codeine Liquid is a sugar free, alcohol free, dye free, gluten free, grape-flavored antitussive/decongestant liquid for oral administration.

Each 5 mL (1 teaspoonful) contains:

*
WARNING: May be habit-forming.
Codeine Phosphate* 10 mg
Pseudoephedrine Hydrochloride 30 mg

Inactive Ingredients: Benzoic Acid USP Powder, Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Methyl Paraben, Natural Masking Flavor, Propyl Paraben, Saccharin Sodium, Sorbitol.

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, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Its structure is as follows:

C18H21NO3 • H3PO4 • ½ H2O         M.W. 406.37

Pseudoephedrine Hydrochloride is a nasal decongestant with the chemical name: Benzenemethanol, α-[1-(methylamino) ethyl]-, [S-(R*, R*)]-, hydrochloride. Its structure is as follows:

C10H15NO • HCl         M.W. 201.69

Pseudoephedrine and Codeine Syrup - Clinical Pharmacology

Codeine Phosphate

Codeine is a centrally acting analgesic and antitussive which is well absorbed orally. Following absorption, codeine is metabolized by the liver and metabolic products are excreted in the urine.

Pseudoephedrine Hydrochloride

Pseudoephedrine 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 CNS stimulation.

Indications and Usage for Pseudoephedrine and Codeine Syrup

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Temporarily reduces the intensity of coughing. Suppresses the impulse to cough to help you rest. Calms the cough control center and relieves coughing. Temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis). Promotes nasal and/or sinus drainage. Temporarily relieves sinus congestion and pressure.

Contraindications

Pseudoephedrine & Codeine Liquid is contraindicated in patients with a known hypersensitivity to any of its ingredients. Do not use in newborn infants, premature infants, in nursing mothers, in patients with severe hypertension, severe coronary artery disease, ischemic heart disease, or in those receiving monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy). Pseudoephedrine & Codeine Liquid 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.

Warnings

Do not exceed the recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Do not take this product if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.

Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy.

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. Pseudoephedrine & Codeine Liquid should be taken a few hours prior to bedtime to minimize the possibility of sleeplessness.

Pseudoephedrine is banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Precautions

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.

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI); certain drugs for depression, psychiatric, or emotional conditions; Parkinson's disease or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Drug Interactions

Do not take Pseudoephedrine & Codeine Liquid if you are presently taking a prescription drug for high blood pressure or depression, without first consulting with a physician. MAO inhibitor therapy (or for 14 days after stopping MAOI therapy), 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 presently taking digitalis glycosides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data is currently available on long-term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans.

Use in Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Pseudoephedrine & Codeine Liquid. It is also not known whether Pseudoephedrine & Codeine Liquid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug.

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Nursing Mothers

Pseudoephedrine & Codeine Liquid is contraindicated in nursing mothers.

Codeine Warning

When physicians prescribe codeine-containing drugs to nursing women, they should inform their patients about the potential risks and the signs of morphine overdose. Nursing women taking codeine need to carefully watch their infants for signs of morphine overdose and seek medical attention immediately if the infant develops increased sleepiness (more than usual), difficulty breastfeeding or breathing, or decreased tone (limpness). Nursing mothers may also experience overdose symptoms such as extreme sleepiness, confusion, shallow breathing or severe constipation. When prescribing codeine to nursing mothers, physicians should choose the lowest effective dose for the shortest period of time and should closely monitor mother-infant pairs.

Drug metabolism is a complex process involving multiple genetic, environmental and physiologic factors. Limited evidence suggests that individuals who are ultra-rapid metabolizers (those with a specific CYP2D6 genotype) may convert codeine to its active metabolite, morphine, more rapidly and completely than other people. In nursing mothers, this metabolism can result in higher than expected serum and breast milk morphine levels. One published case report of an infant death raises concern that nursing babies may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of the drug.

Geriatric Use

Pseudoephedrine should be used with caution in the elderly because they may be more sensitive to the effects of the sympathomimetics. The elderly (60 years of age or older) are more likely to exhibit adverse reactions. Caution should be taken when prescribing this drug to the elderly.

Pediatric Use

Not recommended for use in patients under 12 years of age.

Adverse Reactions

The most common adverse reactions to Pseudoephedrine & Codeine Liquid 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.

Cardiovascular System: Cardiac arrhythmia, increased heart rate, increased blood pressure.

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.

Respiratory: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

Overdosage

Codeine Signs and Symptoms

Overdosage with codeine is characterized by a respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), pinpoint pupils, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest and death may occur.

Pseudoephedrine Hydrochloride Signs and Symptoms

Overdosage with Pseudoephedrine includes anxiety, tenseness, respiratory difficulty, headache and awareness of a slow forceful heartbeat.

Treatment for Codeine and Pseudoephedrine Hydrochloride

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheotomy may be necessary prior to lavage. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

DOSAGE AND ADMINISTRATION1

1
In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.

Adults and children 12 years of age and over

1 to 2 teaspoonfuls (5-10 mL) every 4 to 6 hours. Not to exceed 8 teaspoonfuls in a 24 hour period.

This product is not indicated for use in children under 12 years of age. (see PRECAUTIONS, Pediatric Use.)

How is Pseudoephedrine and Codeine Syrup Supplied

Pseudoephedrine & Codeine Liquid is supplied as a sugar free, alcohol free, dye free, gluten free, grape-flavored antitussive/ decongestant liquid for oral administration. Available in 16 oz. (473 mL) bottles, NDC 51991-665-16.

Store at 25°C (77°F ); excursions permitted to 15° – 30°C (59° – 86°F).See USP Controlled Room Temperature. Protect from freezing.

Dispense in a tight, light-resistant container as defined in the USP/NF.

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

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx Only

Manufactured by:
Provident Pharmaceuticals
Colorado Springs, CO 80919

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

PL382

Iss. 08/09

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Breckenridge
Pharmaceutical, Inc.

NDC 51991-665-16

Pseudoephedrine and
Codeine Liquid

CV

Antitussive • Decongestant
Sugar free • Alcohol free • Dye free

Each 5 mL (1 teaspoonful) contains:

Codeine Phosphate* 10 mg
*(WARNING: MAY BE HABIT-FORMING)
Psedoephedrine Hydrochloride 30 mg

Do not use if safety seal under cap
is broken or missing.

Rx Only

ONE PINT (473 mL)

CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
codeine phosphate and pseudoephedrine hydrochloride syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-665
Route of Administration ORAL DEA Schedule CV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Codeine Phosphate (Codeine) Codeine Phosphate 10 mg  in 5 mL
Pseudoephedrine Hydrochloride (Ephedrine) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Benzoic Acid  
Citric Acid Monohydrate  
Glycerin  
Propylene Glycol  
Water  
Methylparaben  
Propylparaben  
Saccharin Sodium  
Sorbitol  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-665-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/01/2009 11/30/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Provident Pharms Inc. 171901445 MANUFACTURE
Revised: 12/2010
 
Breckenridge Pharmaceutical, Inc.
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