aspirin/chlorpheniramine/phenylephrine

Aspirin/chlorpheniramine/phenylephrine is a combination medication used for the temporary relief of common cold and upper respiratory symptoms, including runny and itchy nose, nasal and sinus congestion, sneezing, cough, watering eyes, headache, and fever. The three medications are combined in specific dosages and the combination is available over the counter (OTC). Each medication works in a different way and together they provide more effective relief than any of them as a single agent.

• Aspirin (acetylsalicylic acid) is one of the oldest and most commonly used non-steroidal anti-inflammatory drugs (NSAIDs). Aspirin inhibits the activity of cyclooxygenases (COX-1 and COX-2), two enzymes that are essential for the synthesis of prostaglandin, a natural substance in the body that initiates inflammation. Inhibition of COX enzymes also inhibits the release of thromboxane A2, a substance that platelets produce to make the blood clot. Aspirin reduces fever by acting on the hypothalamus region of the brain which regulates temperature.
• Chlorpheniramine works by blocking the activity of histamine, a natural compound in the body that causes allergy symptoms. Histamine is released by mast cells and basophils, types of immune cells, in response to allergen exposure. Chlorpheniramine binds to histamine H1 receptors in the smooth muscles of blood vessels and respiratory tract, preventing their activation by histamine that results in allergic reactions such as cough, itching, and other symptoms.
• Phenylephrine belongs to a class of decongestant medications known as alpha1 agonists. Phenylephrine stimulates alpha1 adrenergic receptors, protein molecules located in smooth muscle tissues around blood vessels, making these muscles contract. This constricts the blood vessels in the nasal and sinus passages, reducing congestion.

• Do not take aspirin/chlorpheniramine/phenylephrine if you are hypersensitive to any component of the formulation.
• Do not take aspirin/chlorpheniramine/phenylephrine if you have any of the following conditions:
  • Deficiency of blood-clotting substance prothrombin (hypoprothrombinemia)
  • Vitamin K deficiency
  • Bleeding disorders
  • Narrow-angle glaucoma, an eye condition with high intraocular pressure that damages the optic nerve
  • Prostate enlargement with urinary obstruction
  • Bladder neck obstruction
  • Stenosing peptic ulcer
• Check with your doctor before taking aspirin/chlorpheniramine/phenylephrine if you have any of the following conditions:
  • Liver or kidney disease
  • Thyroid disease
  • Diabetes mellitus
  • History of heartburn or stomach ulcers
  • Asthma, emphysema or chronic bronchitis
  • Glaucoma
• Check with your physician before taking aspirin/chlorpheniramine/phenylephrine if you are on:
  • Diuretics
  • Sodium-restricted diet
  • Sedatives or tranquilizers
  • Medications for gout, arthritis or diabetes
• Do not administer aspirin/chlorpheniramine/phenylephrine in children below 12 years of age.
• Do not administer in children below 16 years of age who have or are recovering from viral infections such as chicken pox or flu-like symptoms. If changes in behavior with nausea and vomiting occur in children after taking the drug, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
• NSAIDs, including aspirin, can cause severe stomach bleeding. Risk factors include:
  • Age above 60 years
  • History of stomach ulcers or bleeding
  • Concurrent use of blood thinners or steroid drugs
  • Concurrent use of other NSAIDs
  • Prolonged use
  • Consumption of 3 or more alcoholic drinks while on treatment
• Do not take aspirin/chlorpheniramine/phenylephrine concurrently or within 14 days after treatment with monoamine oxidase inhibitor (MAOI) type of antidepressant medications.
• Chlorpheniramine can cause drowsiness and taking concurrently with sedatives, tranquilizers or alcohol can increase the drowsiness.

Common side effects of aspirin/chlorpheniramine/phenylephrine include:

• Nausea
• Vomiting
• Indigestion (dyspepsia)
• Aggravation of peptic ulcers
• Heartburn and gastric distress
• Gastrointestinal bleeding
• Gastrointestinal ulceration and perforation
• Loss of appetite (anorexia)
• Prolonged prothrombin time
• Irregular heart rhythm (arrhythmia)
• Rapid heart rate (tachycardia)
• Palpitations
• Low blood pressure (hypotension)
• High blood pressure (hypertension)
• Severe constriction of peripheral and visceral blood vessels
• Thickening of bronchial secretions
• Wheezing
• Headache
• Dizziness
• Fatigue
• Lethargy
• Sedation
• Swelling of brain (cerebral edema)
• Bleeding around the brain (subdural or intracranial hemorrhage)
• Coma
• Agitation
• Confusion
• Irritability
• Insomnia
• Euphoria
• Depression
• Restlessness
• Tremor
• Rash
• Hives
• Low red blood cell count due to premature destruction (hemolytic anemia)
• Low platelet count (thrombocytopenia)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Effervescent tablet

• 325 mg/2 mg/7.8 mg

Adult and Pediatric:

Temporary Relief of Common Cold Cough and Upper Respiratory Symptoms

Children below 12 years old:

• Ask a pediatrician

Adults and children above 12 years old:

• 2 tablets fully dissolved in 4 oz of water once every 4 hours; not to exceed 8 tablets/day

Overdose

• Aspirin overdose can cause salicylate toxicity (salicylism), particularly in children and patients with impaired kidney or liver function. Symptoms include nausea, vomiting, diarrhea, dizziness, loss of hearing, ringing in the ears (tinnitus), lethargy, shortness of breath (dyspnea), or excessive acidity of body fluids (respiratory/metabolic acidosis).
• Chlorpheniramine overdose can cause flushing, fever, hallucinations, weakness, tremor, seizure, and loss of consciousness. In children, overdose may result in excitement first followed by loss of coordination, drowsiness, loss of consciousness, and seizures.
• Phenylephrine overdose can cause headache, vomiting, high blood pressure (hypertension), a reflex drop in the heart rate (bradycardia), a sensation of fullness in the head, tingling of limbs, and irregular heart rhythms (cardiac arrhythmias).
• Aspirin/chlorpheniramine/phenylephrine overdose may be treated with symptomatic and supportive care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of aspirin/chlorpheniramine/phenylephrine include:
  • abrocitinib
  • dichlorphenamide
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • mifepristone
  • phenelzine
• Aspirin/chlorpheniramine/phenylephrine has serious interactions with at least 70 different drugs.
• Aspirin/chlorpheniramine/phenylephrine has moderate interactions with at least 542 different drugs.
• Aspirin/chlorpheniramine/phenylephrine has mild interactions with at least 114 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Avoid taking any medication containing NSAIDs such as aspirin, during pregnancy, including aspirin/chlorpheniramine/phenylephrine, particularly in the third trimester, because aspirin can cause pregnancy complications and fetal harm.
• Aspirin/chlorpheniramine/phenylephrine is present in breastmilk. Do not breastfeed while on treatment with the drug.
• Do not take any OTC drug, including aspirin/chlorpheniramine/phenylephrine, without first checking with your healthcare provider, if you are pregnant or breastfeeding.

• Take aspirin/chlorpheniramine/phenylephrine exactly as prescribed or as per label instructions if taking OTC medication.
• Do not take higher or more frequent doses, do not exceed the daily recommended dosage and do not take for prolonged periods.
• Do not concurrently take other medications that contain aspirin or other NSAIDs such as ibuprofen or naproxen.
• If your sore throat is severe, persists for longer than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult your physician.
• Aspirin can cause severe allergic reactions with symptoms such as hives, facial swelling, wheezing, and shock. If you develop allergic reactions, discontinue the drug immediately and contact your physician.
• Discontinue aspirin/chlorpheniramine/phenylephrine and consult with your physician immediately if you feel faint, have persistent abdominal pain, blood in vomit, and/or black and tarry stools.
• Discontinue use and contact your physician if:
  • Your respiratory symptoms get worse or last longer than 7 days
  • Your fever gets worse or lasts longer than 3 days
  • You have redness or swelling, or new symptoms
  • You develop ringing in the ears or a loss of hearing
  • You experience nervousness, dizziness, or sleeplessness
• Avoid engaging in hazardous activities such as driving or operating heavy machinery while taking aspirin/chlorpheniramine/phenylephrine, because chlorpheniramine can cause drowsiness.
• Avoid drinking alcohol and taking other sedatives or tranquilizers, they may increase drowsiness.
• Store aspirin/chlorpheniramine/phenylephrine safely out of reach of children.
• In case of overdose, seek immediate medical help or contact Poison Control.