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Wockhardt Promethazine w/Codeine Cough Syrup CV 6.25/10mg per 5mL

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Rx Only

  • NDC Code(s): 60432-606-16
  • Packager: Morton Grove Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application
  • Package Size: 473 mL
  • Order Multiple : 12
  • MOQ : 2

$160.00 $120.00  /  0.01328 Ƀ

Categories: , , ID: 2151
(Last Updated On: November 23, 2018)
Generic Name Promethazine with Codeine Cough Syrup CV
Strength 6.25/10mg per 5mL
Description Clear purple syrup with raspberry flavor
FDA Rating AA
Compares To Phenergan® w/Codeine
Therapeutic Category: Antihistamine/Antitussive
Product line: Morton Grove
Imprint Code: n/a
Prescribing Information: Below
ANDA #: 88-875

WOCKHARDT PROMETHAZINE COUGH SYRUP FOR SALE

Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg in a flavored oral solution base with a pH between 4.7 and 5.2. Alcohol 7%.

Inactive Ingredients: Artificial raspberry flavor, ascorbic acid, citric acid anhydrous, D&C Red #33, dehydrated alcohol, edetate disodium, FD&C Blue #1, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate.

Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate.

The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C18H21NO3•H3PO4•½H2O, and the following structural formula:

Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride.
Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S•HCl, and the following structural formula:

WARNING: ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

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.  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). 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. (See WARNINGS – ULTRA-RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).

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 – PROMETHAZINE AND RESPIRATORY DEPRESSION IN CHILDREN).

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 (see WARNINGSPRECAUTIONS – DRUG INTERACTIONS). Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

Codeine

Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression, and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine.

Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine.

Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system.

Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine.

Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating.

Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about 2/3 as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces.

Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours.

The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours.

Promethazine

Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its lack (1/10 that of chlorpromazine) of dopamine antagonist properties.

Promethazine is an H1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

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.

Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated in all children younger than 12 years of age. (See WARNINGS – ULTRA- RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).

Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated for postoperative management in children younger than 18 years who have undergone tonsillectomy and/or adenoidectomy. (See WARNINGS – ULTRA- RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).

Codeine is contraindicated in patients with a known hypersensitivity to the drug.

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma

Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated in all children younger than 12 years of age. (See WARNINGS – ULTRA- RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).

Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated for postoperative management in children younger than 18 years who have undergone tonsillectomy and/or adenoidectomy. (See WARNINGS – ULTRA- RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).

Codeine is contraindicated in patients with a known hypersensitivity to the drug.

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma

Promethazine (proe METH a zeen) with Codeine (KOE deen) Oral Solution, CV

(Promethazine Hydrochloride and Codeine Phosphate Oral Solution)

What is the most important information I should know about Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

  • Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause children to stop breathing (respiratory depression) and cause death.
    • Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children younger than 12 years of age, or to children younger than 18 years of age after tonsillectomy or adenoidectomy surgery.
    • You should not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children between 12 to 18 years of age who have certain risk factors for breathing problems, including:
      • recent surgery
      • obstructive sleep apnea
      • are obese
      • severe lung problems
      • other medical conditions that can cause difficulty breathing, such as neuromuscular problems
      • taking other medicines that cause breathing problems
  • You should not breastfeed during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution because it may cause your child to stop breathing and cause death.
  • Severe drowsiness, breathing problems (respiratory depression), coma, and death can happen in adults and children who take Promethazine Hydrochloride and Codeine Phosphate Oral Solution with benzodiazepines, or other central nervous system depressants, including alcohol.
    • Avoid taking other medicines that can cause drowsiness or sleepiness, or drinking alcohol during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Ask your healthcare provider for a list of these medicines if you are not sure.
  • Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause breathing problems (respiratory depression) and drowsiness.
    • Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as prescribed by your healthcare provider. If you take the wrong dose of Promethazine Hydrochloride and Codeine Phosphate Oral Solution you could overdose and die. See the Medication Guide section called “How should I take Promethazine Hydrochloride and Codeine Phosphate Oral Solution?” for important information about how to take Promethazine Hydrochloride and Codeine Phosphate Oral Solution correctly.
    • Avoid driving a car or operating machinery during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution.
  • Call your healthcare provider or get emergency medical help right away if anyone taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution, or your breastfeeding baby has any of the symptoms below:
    • increased sleepiness
    • confusion
    • difficulty breathing
    • shallow breathing
    • limpness
    • your baby has difficulty breastfeeding
  • Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes Promethazine Hydrochloride and Codeine Phosphate Oral Solution, get emergency medical help right away.

What is Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

  • Promethazine Hydrochloride and Codeine Phosphate Oral Solution is a prescription medicine used to temporarily treat cough and upper respiratory symptoms, including a stuffy nose (nasal congestion) 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 a 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
  • Promethazine Hydrochloride and Codeine Phosphate Oral Solution is not for children under 12 years of age.

Who should not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

  • Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children younger than 12 years of age.
  • Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children younger than 18 years of any age after tonsillectomy or adenoidectomy surgery.
  • Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you are allergic to any of the ingredients in Promethazine Hydrochloride and Codeine Phosphate Oral Solution. See the end of this Medication Guide for a complete list of ingredients in Promethazine Hydrochloride and Codeine Phosphate Oral Solution.
  • Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you have asthma.
  • Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you have high blood pressure or narrowing of blood vessels to your legs or arms (peripheral vascular insufficiency).
  • Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you take a medicine called a Monoamine Oxidase Inhibitor (MAOI).

Before you take Promethazine Hydrochloride and Codeine Phosphate Oral Solution, tell your healthcare provider about all of your medical conditions, including if you:

  • have a drug dependence
  • have lung or breathing problems including chronic obstructive pulmonary disease (COPD), or sleep apnea.
  • have had a head injury
  • have pain in your stomach-area (abdomen)
  • have a history of severe or persistent cough
  • have prostate problems
  • have problems with your urinary tract (urethral stricture) or difficulty urinating
  • have had surgery recently or plan to have surgery
  • drink alcohol
  • have kidney or liver problems
  • have thyroid problems including hypothyroidism
  • have Addison’s disease
  • have glaucoma (increased pressure in eyes)
  • have diabetes
  • have seizures
  • have heart problems or blood vessel (cardiovascular) problems including high blood pressure or peripheral vascular insufficiency See “WHO SHOULD NOT TAKE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION?
  • have blood disorders including low white blood cells
  • are pregnant or plan to become pregnant. It is not known if Promethazine Hydrochloride and Codeine Phosphate Oral Solution will harm your unborn baby. You and your healthcare provider should decide if you should take Promethazine Hydrochloride and Codeine Phosphate Oral Solution while you are pregnant.
  • are breastfeeding or plan to breastfeed. Codeine Phosphate passes into your breast milk and may harm your baby. It is not known if Promethazine Hydrochloride can pass into your breast milk. You should not breastfeed during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution with certain other medicines can cause side effects or affect how well Promethazine Hydrochloride and Codeine Phosphate Oral Solution or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you:

  • take pain medicines such as narcotics
  • take cold or allergy medicines that contain antihistamines or cough suppressants
  • take medicines for mental illness (anti-psychotics, anti-anxiety)
  • drink alcohol
  • take medicines for depression, including monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (TCAs)
  • take medicines for stomach or intestinal problems
  • take ergot containing medicines
  • take medicines called alpha blockers
  • take medicines called beta blockers
  • take stimulants or uppers (amphetamines)

Ask your healthcare provider if you are not sure if you take one of these medicines.

How should I take 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.
  • Your healthcare provider will tell you how much Promethazine Hydrochloride and Codeine Phosphate Oral Solution to take and when to take it. Do not change your dose without talking to your healthcare provider.
  • Ask your pharmacist to give you a measuring device to help you 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 take more than 30 mL of Promethazine Hydrochloride and Codeine Phosphate Oral Solution in 24 hours.
  • If you take too much Promethazine Hydrochloride and Codeine Phosphate Oral Solution, call your healthcare provider or go to the nearest hospital emergency room right away.

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

  • Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause you to be drowsy. Avoid driving a car or operating machinery during the treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Also, watch your child closely when riding a bike.
  • Avoid drinking alcohol during the treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Drinking alcohol can increase your chances of having serious side effects.
  • Avoid spending a long time in sunlight.

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:

  • See “WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION?”
  • Breathing problems (respiratory depression) which can lead to death. Call your healthcare provider or get emergency treatment right away if you have excessive sleepiness, shallow or slow breathing, or confusion.
  • Physical dependence or abuse. Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as your healthcare provider tells you to take it. Stopping Promethazine Hydrochloride and Codeine Phosphate Oral Solution suddenly could cause withdrawal symptoms.
  • Bowel problems including constipation or stomach pain.
  • Increased intracranial pressure.
  • Feeling dizzy, faint or light-headed, especially when you stand up (orthostatic hypotension) . Light-headedness or fainting may happen when getting up too quickly from a sitting or lying position.
  • Neuroleptic malignant syndrome (NMS) which can lead to death. Tell you healthcare provider right away if you have any of the following symptoms of NMS:
    • high fever
    • stiff muscles
    • confusion
    • sweating
    • changes in pulse, heart rate, and blood pressure

The most common side effects of Promethazine Hydrochlorde and Codeine Phosphate Oral Solution include:

  • sleepiness
  • confusion
  • dryness of mouth, nose, throat
  • nausea and vomiting
  • difficulty urinating
  • trouble breathing
  • high blood pressure
  • restlessness
  • fast heart beat

These are not all the possible side effects of Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.

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

  • Store Promethazine Hydrochloride and Codeine Phosphate Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a tightly closed, child-resistant container and out of the light.
  • Safely throw away medicine that is out of date or no longer needed.
  • Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of Promethazine Hydrochloride and Codeine Phosphate Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Promethazine Hydrochloride and Codeine Phosphate Oral Solution for a condition for which it was not prescribed. Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Promethazine Hydrochloride and Codeine Phosphate Oral Solution that is written for health professionals.

What are the ingredients in Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

Active ingredients: promethazine hydrochloride and codeine phosphate

Inactive ingredients: Artificial raspberry flavor, ascorbic acid, citric acid anhydrous, D&C Red #33, dehydrated alcohol, edetate disodium, FD&C Blue #1, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate.

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

26606P

Rev. 11-17

For more information, go to www.wockhardtusa.com or call Wockhardt USA, LLC at 1-800-346-6854.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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