Hydrocodone Bitartrate And Chlorpheniramine Maleate
Pronunciation: (hye-droe-KOE-done / klor-fen-EER-a-meen).
- Generic name
- Hydrocodone bitartrate and Chlorpheniramine maleate
- Brand names
- Hydrocodone Plus, Codil C, Cofhydrin, Tussionex, Vituz, Tussicaps
- Drug class
- Opioid antitussive and first-generation antihistamine combination
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What Hydrocodone bitartrate and Chlorpheniramine maleate is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Hydrocodone bitartrate and Chlorpheniramine maleate works
Hydrocodone is a semi-synthetic opioid agonist that suppresses the cough reflex by direct action on the cough center in the medulla of the brain. Chlorpheniramine is a first-generation antihistamine that competitively inhibits histamine H1 receptors, reducing allergic symptoms such as sneezing and rhinorrhea. This class of product (hydrocodone polistirex/chlorpheniramine polistirex extended-release suspension) carries an FDA boxed warning and, since January 2018, is restricted to adults 18 years and older. (2)
What Hydrocodone bitartrate and Chlorpheniramine maleate is used for
Cough relief associated with upper respiratory symptoms
Cough relief associated with upper respiratory symptoms (2)
Symptomatic relief of allergic rhinitis
Symptomatic relief of allergic rhinitis (2)
Treatment of cold symptoms such as sneezing and runny nose
Treatment of cold symptoms such as sneezing and runny nose (2)
Before taking Hydrocodone bitartrate and Chlorpheniramine maleate
Do not take / not appropriate for
- significant respiratory depression, acute or severe bronchial asthma, known hypersensitivity to either component, and use with MAO inhibitors. (Contraindication) (2)
Tell your clinician about
(2)How to take Hydrocodone bitartrate and Chlorpheniramine maleate
- General Instructions: Take exactly as prescribed by your healthcare provider. Do not exceed the recommended dose or frequency.. Adult Dosing: Typical adult dose: 5 mL (containing 10 mg hydrocodone/8 mg chlorpheniramine) every 12 hours. Maximum: 10 mL in 24 hours. Dosing may vary by product.. Pediatric Dosing: Not recommended for children under 18 years due to risk of respiratory depression and misuse.. Administration: Take by mouth with or without food. Use a proper measuring device for liquid forms. Do not use household spoons.. When To Stop: If you experience severe side effects or an allergic reaction, seek medical attention promptly — let the clinician you see advise on whether to continue or stop this medicine. Do not abruptly stop after prolonged use; consult your doctor, as stopping suddenly after regular opioid use can cause withdrawal symptoms.. Storage: Store at 20-25°C (68-77°F); brief excursions to 15-30°C (59-86°F) are permitted. Keep away from moisture and heat, and out of reach of children and pets.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take an extra dose to catch up.
Overdose
Symptoms of overdose include extreme drowsiness, slow or shallow breathing, pinpoint pupils, cold or clammy skin, or loss of consciousness. Call emergency services or poison control immediately. Naloxone may be used as an antidote for opioid overdose. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Drowsiness
Incidence: Reported in the clinician-authored database; frequency not established
Dizziness
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Constipation
Incidence: Reported in the clinician-authored database; frequency not established
Dry mouth
Incidence: Reported in the clinician-authored database; frequency not established
Respiratory depression
Incidence: Reported in the clinician-authored database; frequency not established
Urinary retention
Incidence: Reported in the clinician-authored database; frequency not established
Confusion
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
FDA BOXED WARNING (the strongest warning the FDA requires) — serious
Symptoms: FDA BOXED WARNING (the strongest warning the FDA requires): (1) Addiction, abuse, and misuse, which can lead to overdose and death. (2) Life-threatening respiratory depression. (3) Accidental ingestion, especially by children, can result in fatal overdose. (4) Concomitant use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (5) Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome in the newborn, which may be life-threatening if not recognized and treated.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Additional warnings from the clinician database, consistent with the boxed warning above — serious
Symptoms: Additional warnings from the clinician database, consistent with the boxed warning above: use with caution in elderly or debilitated patients. In January 2018 the FDA restricted hydrocodone- and codeine-containing cough/cold medicines to adults 18 years and older, removing pediatric indications entirely, because risks in children of all ages were found to generally outweigh benefits.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindications include significant respiratory depression, acute or severe bronchial asthma, known hypersensitivity to either component, and use with MAO inhibitors. Use with caution in patients with chronic pulmonary disease, head injury, increased intracranial pressure, hepatic or renal impairment, elderly, or those with a history of substance abuse.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Hydrocodone/Chlorpheniramine can interact with other medications that cause drowsiness, such as benzodiazepines, other opioids, sleep aids, muscle relaxants, and alcohol. It may also interact with MAO inhibitors, certain antidepressants, and anticholinergic drugs. Always inform your healthcare provider of all medications and supplements you are taking. | (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Not recommended during pregnancy except when a clinician has specifically determined the benefits outweigh the risks. Prolonged opioid use during pregnancy can cause neonatal opioid withdrawal syndrome in the newborn, which can be life-threatening if not recognized and treated. Discuss any pregnancy or plans to become pregnant with your healthcare provider before continuing this medicine. (2)
Breastfeeding
Not recommended during breastfeeding per the clinician database; opioids pass into breast milk and can cause serious harm, including excess sedation and respiratory depression, in a breastfed infant. Discuss safer alternatives with your healthcare provider. (2)
Children
Frequency: Not applicable — not indicated for pediatric use.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not applicable.. Max Single Dose: Not applicable.. Age Restrictions: Since January 2018, the FDA has restricted hydrocodone-containing cough/cold products to adults 18 years and older; they are not indicated for any pediatric age group in the US, regardless of older labeling that may still describe pediatric dosing. (2)
Renal_impairment
The clinician database advises caution in hepatic or renal impairment. Discuss any kidney or liver condition with the prescribing clinician before use. (2)
Hepatic_impairment
The clinician database advises caution in hepatic or renal impairment. Discuss any kidney or liver condition with the prescribing clinician before use. (2)
Monitoring
(2)Storage
Store at 20-25°C (68-77°F); brief excursions to 15-30°C (59-86°F) are permitted. Keep away from moisture and heat, and out of reach of children and pets.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Cough relief associated with upper respiratory symptoms
Dose summary: 5 mL (containing 10 mg hydrocodone and 8 mg chlorpheniramine, as the extended-release polistirex formulation) every 12 hours; maximum 10 mL in 24 hours. (Corrected from an internal DB inconsistency that listed 4 mg chlorpheniramine dosed every 4-6 hours in one field — the 8 mg/every-12-hours figures match both the DB's own administration narrative and the FDA-labeled product.) Adults 18 years and older only.
Renal context: Renal/hepatic-impairment-specific dose adjustment is not established in the clinician-authored database content or the FDA source reviewed for this medicine; use with caution per the clinician database, individualized by the prescriber. (2)
Frequently asked questions
What is Hydrocodone/Chlorpheniramine used for?
It is used to relieve cough and upper respiratory symptoms associated with allergies or the common cold when other treatments are not effective.
Is Hydrocodone/Chlorpheniramine addictive?
Yes, hydrocodone is an opioid and can be habit-forming. Use only as prescribed and never share with others.
Can I take this medication if I am pregnant or breastfeeding?
This medication is not recommended during pregnancy or breastfeeding due to potential risks to the baby. Consult your healthcare provider for alternatives.
What should I do if I experience severe drowsiness or trouble breathing?
Seek immediate medical attention, as these may be signs of overdose or serious side effects.
Can children take Hydrocodone/Chlorpheniramine?
It is not recommended for children under 18 years due to the risk of serious side effects, including respiratory depression.
What should I avoid while taking this medication?
Avoid alcohol, other sedatives, and driving or operating heavy machinery until you know how the medication affects you.
How should I store Hydrocodone/Chlorpheniramine?
Store at 20-25°C (68-77°F); brief excursions to 15-30°C (59-86°F) are permitted. Keep away from moisture and heat, and out of reach of children and pets — accidental ingestion by a child can be fatal.
What happens if I take too much Hydrocodone/Chlorpheniramine?
Taking too much Hydrocodone/Chlorpheniramine can lead to serious overdose symptoms, including severe drowsiness, slowed breathing, pinpoint pupils, extreme muscle weakness, and loss of consciousness. In such cases, it is crucial to seek immediate emergency medical help. Naloxone may be administered to reverse opioid effects.
Can I drink alcohol while taking Hydrocodone/Chlorpheniramine?
No, it is strongly advised to avoid alcohol consumption while taking Hydrocodone/Chlorpheniramine. Both alcohol and this medication can cause central nervous system depression, leading to increased drowsiness, dizziness, impaired coordination, and potentially dangerous respiratory depression. This combination significantly heightens the risk of severe side effects.
Is Hydrocodone/Chlorpheniramine safe during pregnancy?
The safety of Hydrocodone/Chlorpheniramine during pregnancy is not definitively established. It is generally categorized as a medication that requires careful consideration. Due to potential risks to the fetus, including neonatal opioid withdrawal syndrome, it is imperative to consult your healthcare provider to discuss the potential benefits and risks before using this medication if you are pregnant or planning to become pregnant.
What is the mechanism of action of Hydrocodone bitartrate and Chlorpheniramine maleate?
Hydrocodone is a semi-synthetic opioid agonist that suppresses the cough reflex by direct action on the cough center in the medulla of the brain. Chlorpheniramine is a first-generation antihistamine that competitively inhibits histamine H1 receptors, reducing allergic symptoms such as sneezing and rhinorrhea. This class of product (hydrocodone polistirex/chlorpheniramine polistirex extended-release suspension) carries an FDA boxed warning and, since January 2018, is restricted to adults 18 years and older. (2)
What is the generic name of Hydrocodone Bitartrate And Chlorpheniramine Maleate?
The generic name is Hydrocodone bitartrate and Chlorpheniramine maleate. It is sold under brand names including Hydrocodone Plus, Codil C, Cofhydrin, Tussionex, Vituz, Tussicaps.
What class of drug is Hydrocodone bitartrate and Chlorpheniramine maleate?
Hydrocodone Bitartrate And Chlorpheniramine Maleate is classed as: Opioid antitussive and first-generation antihistamine combination.
References
- Hydrocodone/Chlorpheniramine clinician-authored medicine recordMedGuideGlobal · Global (internal clinician record) · accessed 2026-08-06 · source 1
- TUSSIONEX PENNKINETIC (hydrocodone polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIIU.S. Food and Drug Administration · United States · accessed 2026-08-06 · source 2
- Drug Safety Communication: Opioid Cough and Cold Meds - January 2018U.S. Food and Drug Administration · United States · dated 2018-01 · accessed 2026-08-06 · source 3
Brand names by country
Single-ingredient Hydrocodone bitartrate and Chlorpheniramine maleate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.