Codeine, phenylephrine, and triprolidine

Triprolidine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Codeine, phenylephrine, and triprolidine is a combination medicine used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Codeine, phenylephrine, and triprolidine may also be used for purposes not listed in this medication guide.

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Ask a doctor before giving this medicine to a child younger than 12 years old. Do not give this medicine to anyone under 18 who recently had surgery to remove the tonsils or adenoids.

You should not use antihistamine medication to make a child sleepy.

• It is used to treat nose stuffiness.
• It is used to ease allergy signs.
• It is used to relieve coughing.

• Codeine Phosphate, Phenylephrine Hydrochloride, and Triprolidine Hydrochloride
• Phenylephrine, Triprolidine, and Codeine
• Triprolidine, Codeine, and Phenylephrine

Common cold or upper respiratory allergies: Temporarily relieves symptoms due to common cold, hay fever (allergic rhinitis), or other upper respiratory allergies

See individual agents.

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Constipation: Use may cause or aggravate constipation

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.

Special populations:

• Pediatric: Antihistamines may cause excitation in young children.

Other warnings/precautions:

• Appropriate use: When used for self-medication (OTC use), contact health care provider prior to use if you have breathing problems (eg, chronic bronchitis, emphysema, or other chronic pulmonary disease), persistent or chronic cough (eg, cough associated with asthma, emphysema, smoking), a cough with excessive mucus, diabetes, glaucoma, heart disease, hypertension, difficulty urinating due to enlarged prostate, or thyroid disease. Discontinue use and contact health care provider if new symptoms develop; if cough or nasal symptoms persist for >1 week, recur, or are accompanied by a fever, rash, or persistent headache; if dizziness, nervousness, or sleepiness occur. Do not exceed recommended dosage.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience anxiety, insomnia, or sweating a lot. Have patient report immediately to prescriber severe dizziness, passing out, angina, tachycardia, difficulty breathing, slow breathing, shallow breathing, noisy breathing, severe fatigue, confusion, abnormal heartbeat, hallucinations, mood changes, seizures, severe abdominal pain, severe headache, difficult urination, tremors, vision changes, severe nausea, severe vomiting, severe constipation, or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Use with caution

The US FDA has issued a Drug Safety Communication restricting use of prescription codeine pain and cough medicines in children less than 12 years. This update follows previous communications evaluating the potential risks of codeine. Children less than 12 years appear to be at the greatest risk of codeine associated serious adverse events including slowed or difficult breathing and death. The FDA is considering additional regulatory action for over the counter (OTC) combination cough and cold products containing codeine. At this time, it appears prudent to avoid codeine use in all children less than 12 years and avoid use in adolescents between 12 and 18 years who are obese, or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule V