Tussionex Pennkinetic (hydrocodone polistirex/chlorpheniramine polistirex)

Pronunciation: tuss-ee-ON-ex.

Generic name
hydrocodone polistirex and chlorpheniramine polistirex
Drug class
Opioid antitussive (cough suppressant) combined with a sedating antihistamine
Form
Extended-release oral suspension (each 5 mL contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate)
Route
Oral
Legal status
Prescription-only, Schedule II controlled substance (United States)

Availability and supply rules vary by country

Trade names by country: United States

Australia: · Full directory

What hydrocodone polistirex and chlorpheniramine polistirex is and how it works

Tussionex Pennkinetic is a prescription-only, extended-release liquid medicine combining the opioid hydrocodone with the antihistamine chlorpheniramine, used for short-term relief of cough and upper respiratory symptoms in adults. It is a Schedule II controlled substance in the United States because of its opioid content, meaning it carries a real and serious risk of addiction, misuse, and life-threatening breathing problems. (1)

Take this medicine exactly as your prescriber directs, always measured with an accurate milliliter measuring device supplied by your pharmacist -- never a household teaspoon. It is intended only for adults 18 years of age and older and only for the shortest time needed.

Mechanism of action: how hydrocodone polistirex and chlorpheniramine polistirex works

Hydrocodone is a semi-synthetic opioid agonist acting primarily at the mu-opioid receptor to suppress the medullary cough centre; chlorpheniramine is a first-generation H1-antihistamine contributing additional sedating and drying effects. Both components are complexed with polistirex resin to provide extended release over the 12-hour dosing interval. (1)

What hydrocodone polistirex and chlorpheniramine polistirex is used for

Cough and upper respiratory symptoms in adults

Used for temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. It is not indicated for pediatric patients under 18 years of age. If cough does not respond within about 5 days, your prescriber will reassess the diagnosis and treatment. (1)

Before taking hydrocodone polistirex and chlorpheniramine polistirex

Do not take / not appropriate for

  • Do not use this medicine if you are a child younger than 6 years of age. It is contraindicated in this age group and not indicated for anyone under 18. (all countries) (1)
  • Do not use this medicine if you have significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting, or a known or suspected gastrointestinal obstruction (including paralytic ileus). (all countries) (1)
  • Do not use this medicine if you have had a serious allergic reaction to hydrocodone or chlorpheniramine. (all countries) (1)

Tell your clinician about

  • Any personal or family history of substance use disorder, addiction, or misuse of alcohol or drugs.
  • Any history of breathing problems, chronic lung disease, sleep apnea, or head injury.
  • Any history of seizures, low blood pressure, or adrenal gland problems.
  • All other medicines you take, especially anything sedating, any benzodiazepine, or any medicine metabolised by the CYP3A4 enzyme pathway.
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1)

How to take hydrocodone polistirex and chlorpheniramine polistirex

  • Shake well before each use.
  • Measure every dose with an accurate milliliter measuring device provided by your pharmacist -- never use a household teaspoon or tablespoon, which can cause a serious overdose.
  • Do not mix this medicine with other liquids or medicines.
  • Swallow the measured dose; do not take more often or in a larger amount than prescribed.
  • This medicine should be used for the shortest duration consistent with your prescriber's treatment goals.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3)

Missed dose

This medicine is generally taken as needed rather than on a fixed schedule for most patients, but if your prescriber has you on a scheduled regimen and you miss a dose, contact your prescriber or pharmacist for guidance specific to your situation rather than taking an extra dose to make up for it.

Overdose

Overdose can be fatal, especially in children after accidental ingestion of even one dose. Signs can include severe drowsiness, slow or shallow breathing, pinpoint pupils, cold or clammy skin, or loss of consciousness. Call emergency services (or poison control) immediately for any suspected overdose or accidental ingestion, including by a child. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Sedation, drowsiness, mental clouding, or lethargy.

What to notice: Sedation, drowsiness, mental clouding, or lethargy.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Impaired mental and physical performance, lightheadedness, or dizziness.

What to notice: Impaired mental and physical performance, lightheadedness, or dizziness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache, dry mouth, nausea, vomiting, or constipation.

What to notice: Headache, dry mouth, nausea, vomiting, or constipation.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Addiction, abuse, and misuse — boxed_warning

Symptoms: Cravings, using more than prescribed, or continued use despite harm. This risk exists at any dose and any duration of use.

Action: Your prescriber will assess your individual risk before prescribing and monitor you regularly. Tell your prescriber about any personal or family history of substance use so your care can be planned safely. (1)

Life-threatening respiratory depression — boxed_warning

Symptoms: Slow, shallow, or stopped breathing; extreme sleepiness; confusion; blue-tinged lips or fingertips.

Action: Seek emergency medical help immediately. Risk is greatest when starting this medicine, after a dose increase, and when combined with other sedating medicines or alcohol. (1)

Accidental ingestion (especially by a child) — boxed_warning

Symptoms: Any ingestion by someone other than the prescribed adult patient, particularly a child -- even a small or partial amount can be fatal.

Action: Call emergency services or poison control immediately. Store this medicine locked away and out of sight and reach of children at all times. (1)

Profound sedation or respiratory depression from combining with benzodiazepines, other CNS depressants, or alcohol — boxed_warning

Symptoms: Extreme drowsiness, slowed breathing, confusion, coma.

Action: Do not combine this medicine with alcohol, benzodiazepines, or other sedating medicines unless your prescriber has specifically directed this combination and is monitoring you closely. Seek emergency help for any of these symptoms. (1)

Neonatal opioid withdrawal syndrome — boxed_warning

Symptoms: In a newborn whose mother used this medicine for a prolonged period during pregnancy: irritability, poor feeding, tremor, or breathing difficulty in the days after birth.

Action: This requires prompt recognition and treatment by the infant's clinical team; discuss any opioid use during pregnancy with your obstetric and prescribing team as early as possible. (1)

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.

Action: Seek emergency medical help immediately. (1)

Signs of adrenal insufficiency — high caution

Symptoms: Nausea, vomiting, loss of appetite, fatigue, weakness, or low blood pressure occurring with longer-term use.

Action: Tell your prescriber promptly -- this can be diagnosed and treated with corticosteroid replacement if confirmed. (1)

Interactions

  • Alcohol can increase hydrocodone levels in the blood and cause a potentially fatal overdose -- avoid alcohol and any alcohol-containing products while taking this medicine. (1)
  • CYP3A4 inhibitor medicines (certain macrolide antibiotics, azole antifungals, and protease inhibitors) can increase hydrocodone levels and the risk of respiratory depression. (1)
  • CYP3A4 inducer medicines (such as rifampin, carbamazepine, or phenytoin) may reduce this medicine's effect or, if the inducer is later stopped by a clinician, increase hydrocodone exposure. (1)
  • Combining with phenytoin may raise phenytoin levels -- your prescriber will decide whether this combination is appropriate and how to monitor it. (1)
  • Benzodiazepines and other CNS depressant medicines can cause profound sedation, respiratory depression, coma, and death when combined with this medicine. (1)
  • Serotonergic medicines (some antidepressants and migraine medicines) can increase the risk of serotonin syndrome; your prescriber will weigh this risk. (1)
  • MAOI antidepressants should be avoided during treatment and for 14 days after stopping an MAOI, under a prescriber's direction. (1)
  • Muscle relaxants can add to respiratory depression risk. (1)
  • Anticholinergic medicines can increase the risk of severe constipation or paralytic ileus. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

This medicine is not recommended for use in pregnant women. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome in the newborn, which can be life-threatening if not recognised and treated. Discuss any cough treatment during pregnancy with your obstetric and prescribing team. (1) (2) (3)

Breastfeeding

Breastfeeding is not recommended during treatment, because of the risk of excess sedation and respiratory depression in a breastfed infant; hydrocodone passes into breast milk. (1) (2) (3)

Children

Not indicated for anyone under 18 years of age, and contraindicated in children younger than 6 years of age; children are particularly sensitive to hydrocodone's effects on breathing. (1) (2) (3)

Elderly

Patients 65 years and older may be more sensitive to hydrocodone's effects, including respiratory depression; your prescriber may use extra caution and closer monitoring. (1) (2) (3)

Hepatic_impairment

Use with caution in severe liver impairment; your prescriber will monitor for signs of toxicity. (1) (2) (3)

Renal_impairment

Use with caution in severe kidney impairment; your prescriber will monitor for signs of toxicity. (1) (2) (3)

Source_ids

US-DAILYMED-TUSSIONEX-2026 (1) (2) (3)

Monitoring

Before starting

  • Assessment of addiction/misuse risk
  • Review of respiratory and other medical history
  • Review of all other medicines, including any sedating medicines

During treatment

  • Watching for signs of excessive sedation or slowed breathing, especially at treatment start or after a dose change.
  • Periodic reassessment if cough persists beyond about 5 days.
  • Monitoring for signs of misuse or dependence with any ongoing use.
(1)

Storage

Store at controlled room temperature, tightly closed, and protected from light, according to the pharmacy label. Keep this medicine locked away and out of the sight and reach of children and anyone other than the person it was prescribed for -- accidental ingestion, especially by a child, can be fatal.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.

United States

Indication: Cough and upper respiratory symptoms associated with allergy or the common cold, adults 18 years and older

Dose summary: 5 mL (10 mg hydrocodone/8 mg chlorpheniramine) orally every 12 hours as needed, not to exceed 10 mL (2 doses) in 24 hours. Measure only with a calibrated device. Not indicated under 18 years; contraindicated under 6 years. Schedule II controlled substance.

Renal context: Use with caution in severe renal impairment; specific dose-adjustment data not established in the source reviewed for this dossier. (1)

Mechanism of action

Hepatic guidance

Hepatic impairment can alter clearance of both components; a clinician managing severe hepatic impairment will decide on appropriate dose adjustment and monitoring.

Overdose note

Overdose is managed with airway support, ventilatory support, and an opioid antagonist (e.g. naloxone) under emergency medical care; antihistamine toxicity (anticholinergic effects, seizures) may also require supportive management. (1)

Frequently asked questions

Is Tussionex Pennkinetic available in the US, UK, Europe, Canada, Australia, and New Zealand?

It is currently authorised only in the United States, as a Schedule II prescription medicine. A differently-formulated Canadian brand of the same name (using a different antihistamine) was previously marketed in Canada but has since been discontinued. No current authorisation was found in the UK, the EU, Australia, or New Zealand. (1) (3)

Can I take this medicine with alcohol or sleep medicines?

No. Combining this medicine with alcohol, benzodiazepines, or other sedating medicines can cause profound sedation, dangerously slowed breathing, coma, or death. Only your prescriber can decide if any such combination is ever appropriate, with close monitoring. (1)

What happens if a child accidentally swallows this medicine?

This is a medical emergency, even for a single dose. Call emergency services or poison control immediately. (1)

What is the mechanism of action of hydrocodone polistirex and chlorpheniramine polistirex?

Hydrocodone is a semi-synthetic opioid agonist acting primarily at the mu-opioid receptor to suppress the medullary cough centre; chlorpheniramine is a first-generation H1-antihistamine contributing additional sedating and drying effects. Both components are complexed with polistirex resin to provide extended release over the 12-hour dosing interval. (1)

What is the generic name of Tussionex Pennkinetic (hydrocodone polistirex/chlorpheniramine polistirex)?

The generic name is hydrocodone polistirex and chlorpheniramine polistirex. (1)

What class of drug is hydrocodone polistirex and chlorpheniramine polistirex?

Tussionex Pennkinetic (hydrocodone polistirex/chlorpheniramine polistirex) is classed as: Opioid antitussive (cough suppressant) combined with a sedating antihistamine. (1)

References

  1. TUSSIONEX Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) extended-release suspension -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, sanofi-aventis U.S. LLC / Cerecor / current NDA holder · United States · accessed 2026-07-29 · source 1
  2. TUSSIONEX Pennkinetic full prescribing information, label revision 2018 (NDA 019111)U.S. Food and Drug Administration (accessdata.fda.gov) · United States · accessed 2026-07-29 · source 2
  3. TUSSIONEX (Controlled-Release Hydrocodone Resin Complex and Phenyltoloxamine Resin Complex) Prescribing Information, revised November 6, 2018Health Canada product monograph, sanofi-aventis Canada Inc. · Canada · accessed 2026-07-29 · source 3

Brand names by country

Single-ingredient hydrocodone polistirex and chlorpheniramine polistirex names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Tussionex Pennkinetic (hydrocodone polistirex/chlorpheniramine polistirex); generic hydrocodone polistirex and chlorpheniramine polistirex extended-release suspension also marketed (1)FDA approved currently labeled schedule II · 10 mg hydrocodone / 8 mg chlorpheniramine per 5 mL · current NDA 019111 holder (originally Fisons/Celltech; label maintained by current sponsor)
View brands in additional countries.

This page provides general reference information about Tussionex Pennkinetic and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with your prescriber.

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