Chlorpheniramine, ibuprofen, and phenylephrine (Oral)

Chlorpheniramine, ibuprofen, and phenylephrine combination is used to relieve symptoms of allergies and cold, including fever, headache, itching of the nose and throat, itchy, watery eyes, minor aches and pains, sneezing, or runny or stuffy nose. It also helps reduce swelling of the nasal passages and makes breathing easier through the nose.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) included in this combination to help relieve inflammation, swelling, and pain.

This medicine is available as an over-the-counter (OTC) product.

It is very important for your doctor to check your or your child's progress during regular visits to ensure this medicine is working properly and to look for any unwanted effects.

If your or your child's symptoms do not improve within a few days (for example, if a fever lasts more than 3 days, or if a stuffy nose or pain lasts more than 7 days), or if symptoms get worse, contact your doctor.

Using this medicine during late pregnancy can harm your unborn baby. If you think you might be pregnant while using this medicine, inform your doctor immediately.

Do not use this medicine if you have taken an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, within the last 2 weeks.

This medicine may cause a serious allergic reaction, which can be life-threatening and requires immediate medical help. Tell your doctor right away if you experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may cause bleeding in your stomach or bowels. These issues can occur without warning signs. This is more likely if you have had a stomach ulcer before, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (such as NSAIDs, steroids, or blood thinners). Contact your doctor immediately if you have severe stomach pain, black or tarry stools, or if you are vomiting blood or material that looks like coffee grounds.

This medicine may increase your risk of having a heart attack, heart failure, or stroke. This risk is higher in people who already have heart disease. Individuals who use this medicine for a long time may also have an increased risk. Some signs of serious heart issues are chest pain or tightness, a fast or irregular heartbeat, or unusual flushing or warmth of the skin. Contact your doctor right away if you notice any of these warning signs.

This medicine may make you feel dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine will enhance the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants include antihistamines or allergy or cold medicines, sedatives, tranquilizers, sleeping medicines, other prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while using this medicine.

Do not take other medicines unless your doctor has discussed them with you. This includes both prescription and non-prescription (over-the-counter [OTC]) medicines as well as herbal or vitamin supplements.

In deciding to use a medication, the risks of using the medication must be weighed against the good it will do. This is a decision you and your physician will make. For this medicine, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other medications. As well inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific issues that would limit the usefulness of chlorpheniramine, ibuprofen, and phenylephrine combination in children 12 years of age and older. This medication should not be used in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of chlorpheniramine, ibuprofen, and phenylephrine combination in the elderly. However, elderly patients more likely to develop age-related stomach problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks prior to taking this drug while breastfeeding.

Studies in women suggest that this medicine poses minimal chance to the infant when used during breastfeeding.

Interactions with Drugs

Although certain drugs should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially essential that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your physician may decide not to treat you with this drug or change some of the other medications you take.

• Dihydroergotamine
• Ketorolac
• Linezolid
• Potassium Citrate
• Rasagiline
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medications is normally not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the medications.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alfentanil
• Almotriptan
• Amantadine
• Amifampridine
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzhydrocodone
• Benzphetamine
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Buprenorphine
• Bupropion
• Butorphanol
• Cangrelor
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Clozapine
• Codeine
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dihydrocodeine
• Dipyridamole
• Dipyrone
• Dolasetron
• Donepezil
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Ergonovine
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Fosphenytoin
• Furosemide
• Gepirone
• Ginkgo
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gossypol
• Granisetron
• Heparin
• Hydrochlorothiazide
• Hydrocodone
• Hydrocortisone
• Hydroflumethiazide
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Iloprost
• Imipramine
• Indapamide
• Indomethacin
• Inotersen
• Iobenguane I 123
• Iobenguane I 131
• Ketoprofen
• Lasmiditan
• Lepirudin
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Mavacamten
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Meperidine
• Mesalamine
• Metaxalone
• Methacholine
• Methadone
• Methamphetamine
• Methotrexate
• Methyclothiazide
• Methylene Blue
• Methylergonovine
• Methylprednisolone
• Metolazone
• Midodrine
• Milnacipran
• Mirtazapine
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nadroparin
• Nalbuphine
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine Sodium
• Ondansetron
• Opipramol
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Palonosetron
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentazocine
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piretanide
• Piroxicam
• Pitolisant
• Polythiazide
• Potassium Citrate
• Pranoprofen
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quetiapine
• Quinethazone
• Remifentanil
• Revefenacin
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Scopolamine
• Secretin Human
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sufentanil
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tapentadol
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tiotropium
• Tirofiban
• Tocilizumab
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Tramadol
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide
• Zavegepant
• Ziprasidone

Using this drug with any of the following medicines may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your doctor may change the dose or how frequently you use one or both of the medicines.

• Acebutolol
• Amikacin
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain drugs may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following is normally not advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Tobacco

Other Medical Issues

The presence of other medical problems may affect the use of this drug. Make sure you inform your doctor if you have any other medical problems, especially:

• Allergy to aspirin or
• Asthma or
• Diabetes or
• Glaucoma or
• Heart attack, history of or
• Heart disease or
• High blood pressure, history of or
• Kidney disease or
• Liver disease (eg, cirrhosis) or
• Lung or breathing issues (eg, bronchitis, emphysema)
• Stomach ulcers or bleeding, history of or
• Stroke, history of or
• Thyroid issues or
• Trouble urinating caused by enlarged prostate—Use with caution. May make these conditions worse.

• Heart surgery—Should not be used to ease pain right before or after the surgery.

Along with its necessary effects, a medicine can also cause some unwanted effects. Not all of these side effects will happen, but if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects happen:

Incidence not known

• Bloody or black, tarry stools
• Chest pain or tightness
• Confusion
• Constipation
• Cough
• Decrease in urine output
• Diarrhea
• Difficulty speaking
• Difficulty swallowing
• Dilated neck veins
• Dizziness
• Double vision
• Fast heartbeat
• Headache
• Heartburn
• Hives, itching, skin rash
• Inability to speak
• Inability to move the arms, legs, or facial muscles
• Indigestion
• Irregular breathing
• Nausea
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Severe stomach pain, cramping, or burning
• Swelling of the face, fingers, feet, or lower legs
• Trouble breathing
• Unusual tiredness or weakness
• Vomiting blood or material that looks like coffee grounds
• Weight gain

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Nervousness
• Trouble sleeping
• Unusual excitement, especially in children

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Available Dosage Forms:

• Tablet

Therapeutic Class: Analgesic/Decongestant Combination

Pharmacologic Class: Chlorpheniramine

Chemical Class: Chlorpheniramine

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Follow the instructions on the medicine label if you are using this medicine without a prescription.

You may take this medicine with milk or food to avoid stomach upset.

Do not drink 3 or more alcoholic drinks while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For symptoms of allergies and cold: Adults and children 12 years of age and older—1 tablet every 4 hours a day. Do not take more than 6 tablets per day. Each tablet contains 4 milligrams (mg) chlorpheniramine, 200 mg ibuprofen, and 10 mg phenylephrine. Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.