Ibuprofen-Phenylephrine

Ibuprofen-Phenylephrine is an over-the-counter medication used to treat Allergy and Cold Symptoms.

• Ibuprofen-Phenylephrine is available under the following different brand names: Advil Congestion Relief

Common side effects of Ibuprofen-Phenylephrine include:

• Diarrhoea, 
• Constipation.
• Headache, 
• Dizziness, 
• Drowsiness, 
• Weakness.
• Upset stomach, nausea, vomiting, loss of appetite.
• Feeling anxious or excited.
• Sleep problems (insomnia); or
• Flushing (warmth, redness, or tingly feeling).

Serious side effects of Ibuprofen-Phenylephrine include:

• confusion, severe drowsiness, ringing in the ears, severe dizziness, and light-headedness.
• fast, pounding, or uneven heartbeat.
• easy bruising or bleeding (nosebleeds, bleeding gums).
• the first sign of any skin rash, no matter how mild.
• signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
• liver problems --upper stomach pain, vomiting, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems --little or no urinating, painful or difficult urination, swelling or rapid weight gain, feeling tired or short of breath.
• nerve problems --fever, headache, neck stiffness, chills, increased sensitivity to light, seizure (convulsions); or
• severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Rare side effects of Ibuprofen-Phenylephrine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

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

Adult and pediatric dosage

Tablet

• 200 mg/10 mg

Allergy & Cold Symptoms

Adult dosage

• 1 tablet orally every 4 hours as needed while symptoms persist.
• Not to exceed 6 tablets/24 hours

Pediatric dosage

• Below 12 years: Safety and efficacy not established.
• Above 12 years: 1 tablet orally every 4 hours as needed while symptoms persist; not to exceed 6 tablets/24 hours.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, 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.

• Ibuprofen-Phenylephrine has severe interactions with the following drugs.
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • procarbazine
  • selegiline transdermal
  • tranylcypromine
• Ibuprofen-Phenylephrine has serious interactions with at least 53 other drugs.
• Ibuprofen-Phenylephrine has moderate interactions with at least 392 other drugs.
• Ibuprofen-Phenylephrine has minor interactions with at least 104 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice or health questions or concerns.

Contraindications

• Hypersensitivity
• History of induced asthma or urticaria with NSAIDs
• Immediately before or after heart surgery
• Within 2 weeks of MAO inhibitor therapy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ibuprofen-Phenylephrine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ibuprofen-Phenylephrine?”

Cautions

• Caution with hypertension, heart disease, hepatic or renal impairment, asthma, thyroid disease, diabetes, or BPH
• Ibuprofen
  • May increase the risk of GI ulceration.
  • Caution in coadministration with antiplatelets/anticoagulants
  • 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 it was directed or for longer than needed; may decrease the benefit of cardioprotective low dose aspirin
  • Use caution in patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, glaucoma, who have trouble urinating due to an enlarged prostate gland, or who had a stroke.
  • Patients should inform healthcare professionals if they experience symptoms of heart problems or stroke, chest pain, trouble breathing, weakness in one part or side of the body, slurred speech, or leg swelling.
  • If pregnant or breastfeeding, ask a health professional before use; it is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless directed to do so by a doctor; it may cause problems in the unborn child or complications during delivery.
• Phenylephrine
  • May exacerbate poorly controlled hypertension.
  • Caution if underlying cardiovascular risks present.

Pregnancy and Lactation

• Ibuprofen
  • There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.
  • Clinical considerations
    • There are no studies on the effects during labor or delivery.
    • In animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.
• Phenylephrine
  • Data from randomized controlled trials and meta-analyses with use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage.
  • These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores.
  • There are no data on the use during the first or second trimester.
  • Disease-associated maternal and/or embryo-fetal risk
  • Untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting
  • A sustained decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis.
• Lactation
  • Ibuprofen
    • No lactation studies have been conducted; however, limited published literature reports that, following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06-0.6% of the maternal weight-adjusted daily dose; no information is available on the effects of ibuprofen on milk production or a breastfed infant.
  • Phenylephrine
    • No data is available on the presence of phenylephrine injection or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production