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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: hydrocodone and chlorpheniramine (hye dro KOE done and klor fen EER a mine)
Brand name(s): TUSSICAPS
GENERIC: not available FAMILY: Combination antihistamine, decongestants and/or cough preparations
Find the drug label by searching at DailyMed.

Do Not Use [what does this mean?]
Generic drug name: promethazine and codeine (proe METH a zeen)
Brand name(s):
GENERIC: available FAMILY: Combination antihistamine, decongestants and/or cough preparations
Find the drug label by searching at DailyMed.

Do Not Use [what does this mean?]
Generic drug name: promethazine and dextromethorphan (proe METH a zeen/dex tro me THOR phan)
Brand name(s):
GENERIC: available FAMILY: Combination antihistamine, decongestants and/or cough preparations
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

See individual drug families.

Safety Warnings For This Drug [top]

FDA BLACK-BOX WARNING

All codeine- and hydrocodone-containing products have a lengthy FDA-approved black-box warning. The following are highlights from that warning:

Addiction, Abuse and Misuse

Codeine and hydrocodone expose patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death.

Life-Threatening Respiratory Depression

Serious, life-threatening or fatal respiratory depression may occur with use of codeine or hydrocodone.

Accidental Ingestion

Accidental ingestion of codeine or hydrocodone, especially by children, can result in a fatal overdose of codeine.

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 ultra-rapid metabolizers of codeine due to a particular genetic type for a liver enzyme involved in drug metabolism.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of codeine or hydrocodone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated appropriately.

Risks of Concomitant Use with Benzodiazepines or Other CNS Depressants

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

Risk of Medication Errors

Ensure accuracy when prescribing, dispensing and administering hydrocodone. Dosing errors can result in accidental overdose and death.

Interaction with Alcohol

Do not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone. The co-ingestion of alcohol with hydrocodone may result in increased blood levels and a potentially fatal overdose of hydrocodone.

Facts About This Drug [top]

Hydrocodone and chlorpheniramine (TUSSICAPS), promethazine and codeine (generic only), and promethazine and dextromethorphan (generic only) are prescription drug combinations of two ingredients. They should not be used because they are irrational combinations of single ingredients. Although some of the ingredients are safe, effective and sensible to use alone if treating the symptom for which they are intended, the combinations present extra risks from extra ingredients that usually will not...

Hydrocodone and chlorpheniramine (TUSSICAPS), promethazine and codeine (generic only), and promethazine and dextromethorphan (generic only) are prescription drug combinations of two ingredients. They should not be used because they are irrational combinations of single ingredients. Although some of the ingredients are safe, effective and sensible to use alone if treating the symptom for which they are intended, the combinations present extra risks from extra ingredients that usually will not add any benefit to the other ingredient. Further, combination drugs will invariably cost much more than the single ingredient alone. They represent a "shotgun" approach to multiple symptoms of colds, coughs and allergies that rarely occur in force in the combination that is suggested by the ingredients in these products.

Alternative treatments include nose spray or drops for a stuffed nose from a cold (see oxymetazoline, brand name AFRIN) and a single-ingredient oral antihistamine for allergies (see chlorpheniramine, brand names ALERMINE and CHLOR-TRIMETON). The use of an antihistamine can impair healing from a cold. Coughs associated with upper respiratory infections are best not treated with drugs.

For detailed information about an individual ingredient in one of these combination drugs, click on it in the following list: chlorpheniramine, codeine, dextromethorphan, hydrocodone, promethazine.

In 2018, the Food and Drug Administration updated the drug product label of prescription cough and cold medicines containing codeine or hydrocodone to warn that these medicines are not recommended in children younger than 18 years because their risks outweigh their benefits for this age group. Additional safety information on the risks of misuse, abuse, addiction, overdose, death and slowed or difficult breathing has been added to the Boxed Warning of these medicines.[1]

last reviewed February 28, 2021