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:
pseudoephedrine, triprolidine, and codeine
(soo doe e FEH drin and koe deen)
Brand name(s):
TRIACIN-C
GENERIC:
not 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-APPROVED BLACK-BOX WARNING
All codeine-containing products have a lengthy FDA-approved black-box warning. The following are highlights from that warning:
Addiction, Abuse and Misuse
Codeine exposes 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.
Accidental Ingestion
Accidental ingestion of codeine, 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 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, with benzodiazepines or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death.
Facts About This Drug [top]
The prescription-only combination of pseudoephedrine, triprolidine and codeine should not be used because it is an irrational combination of three single ingredients. In general, combination drugs present extra risks because the extra ingredients usually will not add any benefit and instead can increase the risk of side effects. Further, combination drugs will invariably cost much more than the single ingredient alone. It represents a “shotgun” approach to multiple symptoms of colds, coughs...
The prescription-only combination of pseudoephedrine, triprolidine and codeine should not be used because it is an irrational combination of three single ingredients. In general, combination drugs present extra risks because the extra ingredients usually will not add any benefit and instead can increase the risk of side effects. Further, combination drugs will invariably cost much more than the single ingredient alone. It represents a “shotgun” approach to multiple symptoms of colds, coughs and allergies that rarely occurs in force in the combination that is suggested by the ingredients in this product.
Alternative treatments include nose spray or drops for a stuffed nose from a cold (see AFRIN) or a single-ingredient oral antihistamine for allergies (see chlorpheniramine). For a stuffy nose caused by a cold, nasal sprays or drops are much safer than oral drugs because the dose is much lower. It is best not to use drugs to treat coughs associated with upper respiratory infections.
Regulatory actions surrounding pseudoephedrine with codeine
2007: The Food and Drug Administration (FDA) issued a warning concerning the use of codeine products in nursing women who are ultra-rapid metabolizers of codeine. There has been one published case report of an infant death, which raises the concern that nursing babies may be at an increased risk of morphine overdose in these women.[1]
2018: The FDA 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 in 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 black-box warning of these medicines.[2]
last reviewed February 28, 2023
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