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Promethazine Codeine Each 5 ML contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%. Indication: Cough Suppressant Dosage Form: Syrup Validity: 2 years Strength 200 mg 16 oz, 32 oz.

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Before using this medicine

If you are allergic to any drugs like this one, any other drugs, foods, or other substances.

Tell your doctor about the allergy and what signs you had,

like rash;

hives;

itching;

shortness of breath;

cough;

swelling of face,

tongue,throat;

or any other signs.

If you have any of these health problems;

Lung or breathing problems like asthma,

trouble breathing, or sleep apnea,

high levels of carbon dioxide in the blood,

stomach or bowel

block or narrowing.

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Overdose

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.

HOW IS THIS DRUG BEST TAKEN?

Use this drug as ordered by your doctor.

Read all information given to you.

Follow all instructions closely.

drink with or without food.

Take with food if it causes an upset stomach.

Measure liquid doses carefully.

Use the measuring device that comes with this drug.

If there is none, ask the pharmacist for a device to measure this drug.

PROMETHAZINE WITH CODEINE SYRUP

HOW DO I STORE AND/OR THROW OUT THIS DRUG?

Store at room temperature.

Protect from light.

Store in a dry place.

Do not store in a bathroom.

Always keep all drugs in a safe place.

Keep all drugs out of the reach of children and pets.

Throw away unused or expired drugs.

Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs.

There may be drug take-back programs in your area.

WHAT DO I DO IF I MISS A DOSE?

If you take this drug on a regular basis, take a missed dose as soon as you think about it.

If it is close to the time for your next dose, skip the missed dose and go back to your normal time.

Do not take 2 doses at the same time or extra doses.

Many times this drug is taken on an as needed basis.

Do not take more often than told by the doctor.

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WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE- THREATENING RESPIRATORY DEPRESSION IN CHILDREN; PROMETHAZINE AND RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPIOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse

Promethazine HCl and codeine phosphate oral solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

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.

Assess each patient’s risk prior to prescribing promethazine HCl and codeine phosphate oral solution, prescribe promethazine HCl and codeine phosphate oral solution for the shortest duration that is consistent with individual patient treatment goals,

monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment. [see WARNINGS AND PRECAUTIONS (5.1)]

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of promethazine HCl and codeine phosphate oral solution.

Monitor for respiratory depression, especially during initiation of promethazine HCl and codeine phosphate oral solution therapy or when used in patients at higher risk [see WARNINGS AND PRECAUTIONS (5.2)].

Accidental Ingestion

Accidental ingestion of even one dose of promethazine HCl and codeine phosphate oral solution, especially by children, can result in a fatal overdose of codeine [see WARNINGS AND PRECAUTIONS (5.2)].

Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children

Life-threatening respiratory depression and death have occurred in children who received codeine.

Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism [see WARNINGS AND PRECAUTIONS (5.3)].

Promethazine HCl and codeine phosphate oral solution is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see CONTRAINDICATIONS (4)].

Avoid the use of promethazine HCl and codeine phosphate oral solution in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.

Promethazine and Respiratory Depression in Children

Postmarketing cases of respiratory depression, including fatalities have been reported with use of promethazine in pediatric patients.

Children may be particularly sensitive to the additive respiratory depressant effects when promethazine is combined with other respiratory depressants, including codeine. (see WARNINGS AND PRECAUTIONS (5.4).

Risk of Medication Errors

Ensure accuracy when prescribing, dispensing, and administering promethazine HCl and codeine phosphate oral solution. Dosing errors can result in accidental overdose and death.

Always use an accurate milliliter measuring device when measuring and administering promethazine HCl and codeine phosphate oral solution [see DOSAGE AND ADMINISTRATION (2.1), WARNINGS AND PRECAUTIONS (5.7)].

Interactions with Drugs Affecting Cytochrome P450 Isoenzymes

The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.

Avoid the use of promethazine HCl and codeine phosphate oral solution in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor [see Warnings and

Precautions (5.9), DRUG INTERACTIONS (7.1, 7.2, 7.3)].

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Avoid the use of promethazine HCl and codeine phosphate oral solution in patients taking benzodiazepines, other CNS depressants, or alcohol. [see WARNING AND PRECAUTIONS (5.10), DRUG INTERACTIONS (7.4)]

Neonatal Opioid Withdrawal Syndrome

Promethazine HCl and codeine phosphate oral solution is not recommended for use in pregnant women [see USE IN SPECIFIC POPULATIONS (8.1)].

Prolonged use of promethazine HCl and codeine phosphate oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life–threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

If promethazine HCl and codeine phosphate oral solution is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatalopioid withdrawal syndrome and ensure that appropriate treatment will be available