Serious Warnings and Precautions
• If you have glaucoma or difficulty in urination due to an enlarged prostate, do not take this
drug unless directed by a doctor.
• Caution in those with heart failure, high blood pressure or other conditions that may cause
excess fluid collecting in tissues.
• Caution in patients at risk of gastrointestinal tract irritation, including those with a history of
peptic ulcer. The chance of stomach bleeding is higher if you are: age 60 or older, have had
stomach ulcers or bleeding problems, take a blood thinner or steroid drug, take with other
drugs containing an NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or
prescription anti-inflammatory drugs, have 3 or more alcoholic drinks every day while using
this product.
• Caution in Patients at risk of kidney problems, including the elderly or those using diuretics.
• Use during pregnancy or nursing should be avoided.
• Stop use immediately if you have difficulty or pain when urinating.
• Stop use immediately if you have severe skin reactions.

Advil® Cold & Sinus contains ibuprofen, and Pseudoephedrine hydrochloride. Ibuprofen reduces
pain and fever. Pseudoephedrine hydrochloride is a nasal decongestant
Advil® Cold & Sinus caplets is used for fast, temporary relief of the symptoms of colds including
sore throat pain, sinus pain, nasal congestion, headache, fever, body aches and pains.

Do not use Advil Cold & Sinus if you have or are:
➢ allergic/hypersensitive to acetylsalicylic acid (ASA), ibuprofen, other salicylates, other
(NSAIDs), pseudoephedrine or other sympathomimetic amines or any of Advil Cold & Sinus’
ingredients (Refer to the nonmedicinal ingredients section of this insert),
➢ active or recurrent stomach ulcer or gastrointestinal bleeding or active inflammatory bowel
disease (e.g. Crohn’s, colitis),
➢ taking a monoamine oxidase inhibitor (MAOI; e.g. drugs for depression or Parkinson’s disease)
or for 14 days after stopping the MAOI drug, ASA or other NSAIDs including any other
ibuprofen product,
➢ nasal polyps (swelling of the inside of the nose),
➢ asthma,
➢ allergic manifestations such as anaphylaxis (sudden severe life threatening allergic reaction),
urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other
allergic symptoms,
➢ dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake,
➢ been diagnosed with severe high blood pressure or have heart disease,
➢ right before or after heart surgery,
➢ serious liver disease,
➢ severe kidney disease,
➢ thyroid disease,
➢ Raynaud’s Syndrome (a disorder of the circulatory system),
➢ Systemic Lupus Erythematosus,
➢ if you are in your third trimester of pregnancy.

BEFORE you use Advil Cold & Sinus talk to your doctor or pharmacist if you have:
• blood clotting disorder (such as hemophilia)
• breathing problems or chronic lung disease (such as chronic bronchitis)
• diabetes,
• difficulty in urination due to prostate enlargement

• glaucoma
• high blood pressure
• mild to moderate kidney disease
• mild to moderate liver disease
• any other serious disease, are under doctor’s care for any serious condition,
• you are trying to conceive, in your first or second trimester of pregnancy
• or if you are breastfeeding
• or are taking any other drug including over the counter drugs.
Taking Advil® Cold & Sinus with other medicines, herbal, or dietary supplements. Do not
use this product if you are taking:
• a MAOI or if you have stopped taking one within the past two weeks.
• ASA or other anti-inflammatory or pain medication.
Drugs that may interact with Advil Cold & Sinus include:
• acetaminophen
• acetylsalicylic acid (ASA)
• allergy medications
• anticoagulants (blood thinning medications)
• antidepressants
• anti-hypertensives (blood pressure medications)
• antibiotics (levofloxacin)
• benzodiazapines
• cold medications
• corticosteroids
• cyclosporine
• diabetes medication (including insulin and oral antidiabetic agents)
• digoxin
• diuretics (water pills)
• lithium
• methotrexate
• monoamine Oxidase Inhibitors
• nonsteroidal anti-inflammatory drugs (NSAIDs); including naproxen and ibuprofen
• phenytoin
• probenecid
• thyroxine
Tell your doctor or pharmacist what prescription or non-prescription drugs you are taking or plan to take.

Do not smoke or drink alcohol while using this product.
Pregnancy and Lactation
Do not use if you are trying to conceive, in your first or second trimester of pregnancy or if you are breastfeeding

Usual dose:
Adults and children 12 to 65 years: Take 1 or 2 caplets every 4-6 hours as needed. Do not exceed 6
caplets in 24 hours, unless directed by a doctor.
Do not give to children under 12. Do not use longer than 3 days for a fever or 5 days for pain or cold
symptoms.

If you take more Advil® Cold & Sinus than you should:

In case of accidental overdose, discontinue use and seek professional assistance immediately
even if there are no symptoms

If you forget to take Advil® Cold & Sinus
Continue to take 1 or 2 caplets every 4 to 6 hours as needed after a missed dose. Do not take twice the
recommended dose following a missed dose.

Take with food or milk if upset stomach occurs.
Advil Cold & Sinus may occasionally produce unwanted side effects, such as heartburn, constipation,
nausea, bloating, severe skin reactions, nervousness or sleeplessness.
Stop use and contact a doctor or pharmacist if these symptoms worsen or persist.
The risk of having side effects may be decreased by using the smallest dose for the shortest duration
of time

This is not a complete list of side effects. For any unexpected effects while taking Advil Cold & Sinus,
contact your doctor or pharmacist.

To report any side affect(s):
• Saudi Arabia:
The National Pharmacovigilance Centre (NPC):
- SFDA Call Center: 19999
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa
- Other GCC States: Please contact the relevant competent authority.

Store below 30°C.
Keep out of reach of children. This package contains enough medicine to seriously harm a child.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.