Chlorpheniramine/Dextromethorphan/Acetaminophen, Oral

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KEY POINTS

• This medicine is taken by mouth to relieve the symptoms of colds or flu. Take it exactly as directed.
• This medicine may cause severe liver damage or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antihistamine/antitussive/analgesic (pain reliever)

Generic and brand names: chlorpheniramine/dextromethorphan/acetaminophen, oral; Coricidin HBP Maximum Strength Flu; Triaminic Multi-Symptom Fever; Children’s Tylenol Plus Cough and Runny Nose; Alcohol-Free NyQuil Cold & Flu Relief; Vicks Formula 44 Custom Care Cough and Cold PM (There may be other brand names for this medicine.)

What is this medicine used for?

This medicine combines a cough suppressant, an antihistamine, and a pain reliever. It is taken by mouth to relieve the symptoms of colds or flu.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergy to any medicine
• A blockage in the intestines, Crohn's disease, or ulcerative colitis
• Asthma or other breathing problems, including a cough
• Diabetes
• Glaucoma
• Heart disease or heart rhythm problems
• High blood pressure
• Kidney or liver disease
• Phenylketonuria (PKU). This medicine may contain phenylalanine.
• Thyroid problems
• Trouble urinating or an enlarged prostate gland
• Ulcers

Do not take this medicine if you have taken an MAO inhibitor within the last 14 days. Using these products together can cause very serious side effects.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes or carefully follow the directions on the package. Do not take more medicine or take it more often than directed because of the increased risk of side effects. Check medicine labels carefully before using two or more medicines at the same time. Other prescription and nonprescription cold and allergy medicines may contain the same kind of medicine, and you may take too much. Ask your healthcare provider or pharmacist about anything you do not understand.

Check with your healthcare provider before using this medicine in children under age 12.

If you are using the liquid form of this medicine, use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct. Some liquid forms of this medicine (suspensions) may need to be shaken well before use.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: cold clammy skin, confusion, dark urine, drowsiness, extreme dizziness, fainting, fast or irregular heartbeat, flushing, hallucinations, nausea, pinpoint pupils, slow shallow breathing, stomach pain, sweating, vomiting, seizures, coma.

What should I watch out for?

Do not give a child under age 4 any cough and cold medicines unless specifically instructed to do so by your healthcare provider. If your child is over the age of 4, ask your healthcare provider before giving cough and cold medicines.

The antihistamine and cough suppressant in this medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

The antihistamine and cough suppressant increases the effects of alcohol and other drugs that slow down the central nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

This medicine may cause severe liver damage if:

• An adult takes more than 4000 mg of acetaminophen in 24 hours
• A child takes more than 5 doses in 24 hours
• You take this medicine with other drugs that contain acetaminophen
• An adult has 3 or more alcoholic drinks every day while using this product

If you do not know how much acetaminophen is in your medicine, ask your pharmacist. Many nonprescription products such as those for pain, cold and flu, allergy, and sleeplessness contain acetaminophen. Check the label or ask your pharmacist to avoid taking too much acetaminophen.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

Adults over the age of 65 may be at greater risk for side effects. Talk with your provider about this.

Contact your healthcare provider if your symptoms do not improve or get worse after taking the medicine for a few days.

If you need emergency care, surgery, allergy skin tests, lab tests, or dental work, tell the healthcare provider you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fast or irregular heartbeat; chest tightness or pain; seizures; extreme tiredness; unusual bruising or bleeding; trouble urinating; mood changes; sore throat; fever; slowed breathing; loss of vision; severe confusion or hallucinations; dark urine; severe stomach pain; severe nausea or vomiting; yellowing of skin or eyes; light-colored bowel movements; severe rash or peeling skin.

Other: Drowsiness, dizziness, loss of appetite, blurred vision, dry mouth, nervousness, nausea, constipation, trouble sleeping, headache.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, chlordiazepoxide, clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), dronedarone (Multaq), and quinidine
• Anticholinergic medicines such as amantadine (Symmetrel), atropine/diphenoxylate (Lomotil), belladonna, benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), and vilazodone (Viibryd)
• Antifungal medicines such as ketoconazole (Nizoral) and terbinafine (Lamisil)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), pimozide (Orap), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clobazam (Onfi), phenytoin (Dilantin, Phenytek), and valproic acid (Depacon, Depakene, Depakote)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bladder control medicines such as darifenacin (Enablex), mirabegron (Myrbetriq), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), and tolterodine (Detrol)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Bupropion/naltrexone (Contrave)
• Cancer medicines such as abiraterone (Zytiga), nilotinib (Tasigna), and procarbazine (Matulane)
• Celecoxib (Celebrex)
• Cinacalcet (Sensipar)
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• HIV medicines such as delavirdine (Rescriptor), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and tipranavir (Aptivus)
• Isoniazid
• Linezolid (Zyvox)
• Lorcaserin (Belviq)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), ipratropium (Atrovent), tiotropium (Spiriva), umeclidinium (Incruse Ellipta), and umeclidinium/vilanterol (Anoro Ellipta)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, melatonin, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira)
• Other allergy, cold, or cough medicines that contain an antihistamine, cough suppressant, or decongestant
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), pentazocine (Talwin), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Quinine
• Sleeping pills such as suvorexant (Belsomra), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as dextroamphetamine (Dexedrine) and methamphetamine (Desoxyn)
• Tedizolid (Sivextro)
• Warfarin (Coumadin)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.