Ibuprofen/Pseudoephedrine

Ibuprofen/pseudoephedrine is an over-the-counter (OTC) product used to treat cold symptoms.

Ibuprofen/pseudoephedrine is available under the following different brand names: Advil Cold and Sinus.

Dosages of Ibuprofen/Pseudoephedrine:

Dosage Forms and Strengths

Caplet

• 200mg/30mg

Liquid Gel Capsule

• 200mg/30mg

Dosage Considerations – Should be Given as Follows:

Cold Symptoms

• Adults and children over 12 years: 1 caplet/capsule orally every 4-6 hours as needed; may increase to 2 caplets/capsules every 4-6 hours if necessary while symptoms persist
• Not to exceed 6 doses/24 hours
• Children under 12 years: Safety and efficacy not established
• Administration
• Take with food or milk if stomach upset occurs

Side effects of ibuprofen/pseudoephedrine include:

• Gastrointestinal upset
• Insomnia
• Irregular heartbeats (arrhythmia)
• Palpitations
• Convulsion
• Dizziness
• Drowsiness
• Excitability
• Headache
• Tremor
• Weakness
• Nausea
• Vomiting
• Hemolytic anemia
• Aplastic anemia
• Bronchospasm
• Congestive heart failure
• Exfoliative dermatitis
• Constipation
• High blood pressure (hypertension)
• Low white blood cells (neutropenia)
• Thromboembolism
• Abdominal pain
• Anxiety
• Central nervous system (CNS) stimulation
• Liver toxicity
• Dizziness

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of ibuprofen/pseudoephedrine include:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • procarbazine
  • rasagiline
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Ibuprofen/pseudoephedrine has serious interactions with at least 52 different drugs.
• Ibuprofen/pseudoephedrine has moderate interactions with at least 293 different drugs.
• Ibuprofen/pseudoephedrine has mild interactions with at least 35 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains ibuprofen/pseudoephedrine. Do not take Advil Cold and Sinus if you are allergic to ibuprofen/pseudoephedrine or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Immediately before or after heart surgery
• History of inducing asthma or urticaria with nonsteroidal anti-inflammatory drugs (NSAIDs)
• Do not use with monoamine oxidase inhibitors (MAOIs) or for 2 weeks after discontinuing MAO inhibitors because of risk for hypertensive crisis

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Ibuprofen/Pseudoephedrine?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Ibuprofen/Pseudoephedrine?”

Cautions

• Caution with hypertension, heart disease, hepatic or renal impairment, asthma, thyroid disease, diabetes, BPH, peptic ulcer disease
• Nonsteroidal Anti-Inflammatory Drug (NSAID) content
• May increase risk for gastrointestinal ulceration, increased risk if age is over 60 years or history of peptic ulcer disease
• Caution in coadministration with antiplatelets/anticoagulants
• May decrease benefit of cardioprotective low-dose aspirin
• NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke; which can be fatal; the risk is higher if patients use more than was directed or for longer than needed
• Use caution in patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, glaucoma, have trouble urinating due to an enlarged prostate gland or had a stroke
• Patients should inform healthcare professionals if they have symptoms of heart problems or stroke, chest pain, trouble breathing, weakness in one part or side of the body, slurred speech, leg swelling
• Pseudoephedrine
• May exacerbate poorly controlled hypertension
• Caution if underlying cardiovascular risks present

Pregnancy and Lactation

• Use ibuprofen/pseudoephedrine with caution during pregnancy in the first 2 trimesters if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done. Use ibuprofen/pseudoephedrine during the last 3 months of pregnancy in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk. Do not take NSAIDs within 3 months before delivery because of the risk for premature closure of the ductus arteriosus.
• Ibuprofen/pseudoephedrine is excreted in breast milk. The American Academy of Pediatrics (AAP) states it is compatible with breastfeeding. Consult your doctor.