What is Quagen Promethazine & Codeine Phosphate?

Quagen Promethazine & Codeine Phosphate Oral Solution is an opioid pain reliever which is used to treat mild to moderately severe pain and to help reduce coughing. Codeine is available as a single ingredient tablet and also available in multi ingredients products combined with other pain relieving medicines or cold and flu medicines.

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What is Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

Promethazine Hydrochloride and Codeine Phosphate Oral Solution is a prescription medicine used in adults to temporarily treat cough and upper respiratory symptoms that you can have with allergies or a common cold.
Promethazine Hydrochloride and Codeine Phosphate Oral Solution contains 2 medicines, promethazine and codeine. Promethazine is an antihistamine. Codeine is an opioid (narcotic) cough suppressant.
Promethazine Hydrochloride and Codeine Phosphate Oral Solution is a federal controlled substance (C-V) because it contains codeine that can be abused or lead to dependence. Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place to prevent misuse and abuse. Selling or giving away Promethazine Hydrochloride and Codeine Phosphate Oral Solution may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Whats the Color of Quagen Codeine Syrup ?

PRODUCT CHARACTERISTICS
Color	purple (PURPLE)	Score
Shape		Size
Flavor	RASPBERRY (artificial and natural raspberry flavor)	Imprint Code
Contains

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL

INDICATIONS AND USAGE

Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.

Important Limitations of Use

Not indicated for pediatric patients under 18 years of age.
Contraindicated in pediatric patients under 12 years of age.
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Promethazine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

Recommended Dosage

Adults 18 years of age and older: 5 mL every 4 to 6 hours as needed, not to exceed 6 doses (30 mL) in 24 hours.

Oral solution: Each 5 mL contains 10 mg of codeine phosphate and promethazine hydrochloride in a flavored syrup base.

Important Dosage and Administration Instructions

Administer Promethazine HCl and Codeine Phosphate Oral Solution by the oral route only. Always use an accurate milliliter measuring device when administering Promethazine HCl and Codeine Phosphate Oral Solution to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage

CONTRAINDICATIONS

Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated for: All children younger than 12 years of age [see Warnings and Precautions.

WARNINGS AND PRECAUTIONS

5Addiction, Abuse, and Misuse – Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, a Schedule V controlled substance. As an opioid, Promethazine HCl and Codeine Phosphate.

What are the possible side effects of Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

Promethazine Hydrochloride and Codeine Phosphate Oral Solution may cause serious side effects, including:

The most common adverse reactions to Promethazine HCl and Codeine Phosphate Oral Solution include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, sweating.

Other reactions include:

Anaphylaxis: Anaphylaxis has been reported with codeine, one of the ingredients in Promethazine HCl and Codeine Phosphate Oral Solution.

Body as a whole: Coma, death, fatigue, falling injuries, lethargy.

Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush.

Central Nervous System: Ataxia, diplopia, facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tinnitus, tremor, vertigo.

DRUG INTERACTIONS

No specific drug interaction studies have been conducted with Promethazine HCl and Codeine Phosphate Oral Solution. Inhibitors of CYP3A4 – The concomitant use of Promethazine HCl and Codeine.

USE IN SPECIFIC POPULATIONS

Pregnancy – Risk Summary – Promethazine HCl and Codeine Phosphate Oral Solution is not recommended for use in pregnant women, including during or immediately prior to labor.

DRUG ABUSE AND DEPENDENCE

Controlled Substance – Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, a Schedule V controlled substance. Abuse – Codeine – Promethazine HCl and Codeine Phosphate.

OVERDOSAGE

Clinical Presentation – Codeine – Acute overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis).

DESCRIPTION

Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, an opioid agonist, and promethazine, a phenothiazine. Each 5 mL of Promethazine HCl and Codeine Phosphate Oral Solution.

CLINICAL PHARMACOLOGY

Mechanism of Action – Codeine – Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic and antitussive.

HOW SUPPLIED/STORAGE AND HANDLING

Promethazine HCl and Codeine Phosphate Oral Solution, 6.25 mg and 10 mg per 5 mL, is a clear, purple solution, supplied as:

NDC Number Size

70752-139-06 4 fl. oz. (118 mL) bottle

70752-139-12 16 fl. oz. (473 mL) bottle

Keep bottles tightly closed.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Dispense in tight, light-resistant container (USP/NF) with a child-resistant closure.

Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed.

How should I take Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

See “What is the most important information I should know about Promethazine Hydrochloride and Codeine Phosphate Oral Solution?”
Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as your healthcare provider tells you to take it. Do not change your dose without talking to your healthcare provider.
Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution by mouth only.
Do not take more than 30 mL of Promethazine Hydrochloride and Codeine Phosphate Oral Solution in 24 hours.
Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution using an accurate milliliter (mL) measuring device. If you do not have one, ask your pharmacist to give you a measuring device to measure the correct amount of Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
Do not overfill the measuring device

MEDICATION GUIDE

Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from children. Accidental use of even 1 dose of Promethazine Hydrochloride and Codeine Phosphate Oral Solution, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death. If a child accidentally takes Promethazine Hydrochloride and Codeine Phosphate Oral Solution, get emergency help right away.

What should I avoid while taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

Avoid driving a car or operating machinery during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause you to be drowsy, slow your thinking and motor skills, and affect your vision.
Do not drink alcohol during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Drinking alcohol with Promethazine Hydrochloride and Codeine Phosphate Oral Solution can increase your chances of having serious side effects, accidental overdose, and cause death.

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