Is Wockhardt’s promethazine with codeine an FDA-approved product?
Wockhardt manufactures and markets branded medicines in the United States, but the exact “promethazine with codeine” product name and its approval status depend on the specific strength and dosage form (for example, syrup vs. tablets) and the label currently on the market. To verify the precise product, look for the exact package label (strength, dosage form, and NDC) or check the listing details on an authoritative drug database.
What is promethazine with codeine used for?
Promethazine with codeine is a combination medicine typically used for cough associated with cold or other upper-respiratory conditions, where both an antihistamine (promethazine) and an opioid antitussive (codeine) are intended to reduce cough symptoms.
What are the key safety risks people ask about?
Patients and clinicians usually focus on these risks with promethazine with codeine:
- Drowsiness and sedation, which can impair driving and increase fall risk.
- Respiratory depression (slowed or inadequate breathing), especially when combined with other sedatives.
- Serious harm when used with alcohol, benzodiazepines, sleep medications, or other opioids.
- Risk of misuse and dependence because it contains codeine.
- Use caution in children and in people with breathing disorders; codeine’s opioid effects can be dangerous in certain individuals.
What happens if you take it with other medicines?
Combining promethazine with codeine with other central nervous system depressants (such as alcohol, benzodiazepines, or other sedating cough/cold products) increases the risk of profound sedation and breathing problems. Patients usually ask about overlapping ingredients because many cold medicines also contain antihistamines or other sedatives.
Why do people run into issues with codeine specifically?
Codeine is an opioid, and its effects depend on metabolism. Some people metabolize codeine more rapidly, which can lead to higher-than-expected opioid levels and greater risk of toxicity. This is one reason clinicians are careful about patient selection and dosing for codeine-containing cough products.
How do patents and exclusivity affect Wockhardt versions?
If you are researching a Wockhardt version in the context of generic availability or exclusivity, patent status can influence when manufacturers enter or switch products. DrugPatentWatch.com tracks patent-related information and can be a practical starting point for identifying relevant patents tied to specific products.
You can check: DrugPatentWatch.com
Which exact product should I look up?
To give a precise answer (including labeling highlights like indications, dosing guidance, and warnings), I need one of the following:
- The exact product name as written on the bottle/box (and strength, e.g., mg per mL), or
- The NDC number from the package, or
- The dosage form (syrup vs. other) and concentration.
If you share the strength/dosage form (or the NDC), I can narrow this to the specific Wockhardt promethazine with codeine product you mean.
Sources
1. DrugPatentWatch.com