Clinically Proven Efficacy In Sore Throat Pain In Children
Ibuprofen offered statistically significant effective sore throat relief compared to placebo and longer duration of pain relief compared to acetaminophen in children as seen in the following study:7
Clinical Pharmacology and Therapeutics, 1993
- A double-blind, single dose parallel study was conducted to evaluate treatment of sore throat pain in children. Statistically significant differences compared to placebo were noted at 30 minutes and from 25 hours. The acetaminophen treatment group notes statistically significant differences from 30 minutes to 4 hours. This may suggest that ibuprofen offers longer duration of pain relief than acetaminophen7*
* Schachtel BP et al., 1993 conducted a double-blind, placebo-controlled, single-dose parallel study in 116 children from 2 to 12 years of age with acute sore throat. Measurements were done at 30 minutes and every hour thereafter for 6 hours. Children assessed pain intensity with a pain thermometer and pain relief with a smiley-face scale. The parent and pediatrician assessed pain intensity and change in pain the parent also provided an overall evaluation at 6 hours. The children rated ibuprofen and acetaminophen as significantly effective compared with placebo on both scales at most posttreatment time points and overall. The parent and pediatrician also rated both active medications as significantly different from placebo on both of their scales at several time points and overall.
Stop Use And Ask A Healthcare Provider If
- An allergic reaction occurs, seek medical attention immediately
- You get nervous, dizzy or sleepless
- You have nasal congestion that lasts more than 7 days
- Your symptoms continue or get worse
- You have trouble swallowing or you feel like the caplet is stuck in your throat
- New or unexpected symptoms occur
- You have stomach pain that begins while taking this product or mild stomach problems that do not go away
- You have a fever that lasts longer than 3 days
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Typical Dosing For Ibuprofen/pseudoephedrine
Each caplet contains 200 mg of ibuprofen and 30 mg pseudoephedrine.
- Adults and children age 12 years and up: The typical dose is 1 caplet by mouth every 4 to 6 hours while you’re having symptoms. If your symptoms don’t get better with 1 caplet, you can take 2 caplets. Don’t use more than 6 caplets in 24 hours unless your provider specifically told you to do so.
- Children age less than 12 years: Do not use.
What Are The Dosages Of Ibuprofen/pseudoephedrine
Dosages of Ibuprofen/Pseudoephedrine:
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
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Overdosage Of Advil Cold Sinus Tablet
- Do not use more than prescribed dose. Taking more medication will not improve your symptoms rather they may cause poisoning or serious side-effects. If you suspect that you or anyone else who may have overdosed of Advil Cold Sinus Tablet, please go to the emergency department of the closest hospital or nursing home. Bring a medicine box, container, or label with you to help doctors with necessary information.
- Do not give your medicines to other people even if you know that they have the same condition or it seems that they may have similar conditions. This may lead to overdosage.
- Please consult your physician or pharmacist or product package for more information.
Advil Sinus Congestion & Pain Interactions:
Hypertensive crisis with MAOIs. -blockers may increase the pressor effects of sympathomimetics. Caution with diuretics. Avoid aspirin, other pain relievers, nasal decongestants, or phenylephrine-containing products. Increased risk of GI bleed with anticoagulants, corticosteroids, other OTC or Rx NSAIDs, 3 alcoholic drinks/day, or prolonged use.
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What Are The Side Effects Of Ibuprofen/pseudoephedrine
With any medication, there are risks and benefits. Even if the medication is working, you may experience some unwanted side effects.
Contact your doctor immediately if you experience any of the following:
- Heart attack: chest pain or tightness, pain that radiates up to your shoulder, arm, neck, or jaw
- Stroke: chest pain, trouble breathing, weakness in one part of your body or face, slurred speech, leg swelling
- Stomach bleeding: feeling faint, vomiting blood, bloody or dark stools, severe stomach pain or discomfort
- Allergic reactions: hives, rash, blisters, swelling of the lips or tongue, difficulty breathing, skin reddening
The following side effects may get better over time as your body gets used to the medication. Let your doctor know immediately if you continue to experience these symptoms or if they worsen over time.
How Should I Use This Medication
The usual recommended dose for adults and children older than 12 years is 1 or 2 caplets or liqui-gels every 4 to 6 hours as needed. Do not take more than 6 caplets or liqui-gels in 24 hours unless recommended by your doctor. Do not take for more than 3 days for a fever or for more than 5 days for cold symptoms.
For the childrens suspension, the dose depends on the childs age and weight and is given every 6 hours as needed. Do not give more than 4 doses a day unless recommended by your doctor. Use an oral syringe or medication cup to measure each dose of the suspension, as it gives a more accurate measurement than household teaspoons. Shake the suspension well before measuring a dose.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the one listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as recommended by your doctor or pharmacist. If you are taking this medication regularly and you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
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Advil Sinus Congestion & Pain
Advil Sinus Congestion & Pain combines the speed and strength of Advil and a proven nasal decongestant for fast, effective relief of sinus pressure and congestion associated with colds. Though mucus can contribute to the stuffed up feeling, nasal congestion is the swelling of the tissues in the nose and sinuses caused by inflammation. Advil Sinus Congestion & Pain re-opens your airways by constricting the blood vessels in your nose and sinuses.
Advil Sinus Congestion & Pain also treats the pain associated with colds. The philosophy behind Advil Sinus Congestion & Pain is that cold-sufferers who treat only nasal congestion or the pain associated with it really only address half the problem. Both pain and congestion are major symptoms of colds so it just makes sense to treat them both with just one tablet. Get fast, powerful relief with Advil Sinus Congestion & Pain.
Featured on Prevention.com in 11 Cold Medicines That Will Make You Feel Less Miserable. Read the full article.
Temporarily relieves these symptoms associated with the common cold or flu:
- headache
12 years of age and older:
- 1 tablet every 4 hours while symptoms persist.
- Do not use more than 6 tablets in 24 hours unless directed by a doctor.
Under 12 years of age
- Do not use
*Nonsteroidal anti-inflammatory drug
Inactive Ingredients:
Use as directed. Read complete warnings and information.
Advil Cold & Sinus Side Effects
Get emergency medical help if you have signs of an allergic reaction or a severe skin reaction .
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using Advil Cold & Sinus and call your doctor at once if you have:
-
confusion, severe drowsiness, ringing in your ears, severe dizziness, feeling like you might pass out
-
fast, pounding, or uneven heartbeat
-
easy bruising or bleeding
-
a 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–loss of appetite, stomach pain , tiredness, itching, dark urine, clay-colored stools, jaundice
-
kidney problems–little or no urination, swelling in your feet or ankles, feeling tired or short of breath or
-
nerve problems–fever, headache, neck stiffness, chills, increased sensitivity to light, seizure .
Common side effects may include:
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What Are The Mild And More Common Side Effects Of Advil Cold & Sinus
All medications have side-effects. Consumers taking Advil Cold & Sinus potentially have a wide range of side effects. For example, the most common symptoms experienced by sinus sufferers after taking the medication include:
- Constipation
- Sudden changes in speech or vision
Of the above side effects, the most frequent are a rapid or irregular heartbeat, persistent drowsiness and severe vomiting. Contact your doctor if you feel the onset of any of these symptoms.
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Are There Any Other Precautions Or Warnings For This Medication
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
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Advil Sinus Congestion & Pain Warnings/precautions:
Increased risk of severe stomach bleeding . History of GI disorders . Increased risk of heart attack or failure, and stroke. Hypertension. Heart disease. Recent stroke. Liver cirrhosis. Renal disease. Asthma. Thyroid disease. Diabetes. GI or urinary obstruction. Reevaluate if fever persists or worsens > 3 days or pain/nasal congestion lasts > 7 days. Elderly. Pregnancy : not recommended. Nursing mothers.
What Other Drugs Interact With Ibuprofen/pseudoephedrine
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:
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.
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What Should I Know About Storage And Disposal Of This Medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture .
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.
What Other Information Should I Know
If you are taking the 24-hour extended-release tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.
Ask your pharmacist any questions you have about pseudoephedrine.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Advil Cold And Sinus Overview
Advil Cold and Sinus is an over the counter medication used to treat the symptoms of colds, sinus congestion, and the flu. It is a single product containing 2 medications: ibuprofen and pseudoephedrine. Advil Cold and Sinus belongs to a group of drugs called non-steroidal anti-inflammatory drugs and nasal decongestants. It works by providing pain/headache relief while reducing the congestion of the sinuses and nasal passages.
This medication comes in a caplet and capsule form and is taken every 4 to 6 hours, with a maximum of 6 caplets/capsules per day. Advil Cold and Sinus may be taken with food or milk.
Common side effects of Advil Cold and Sinus include stomach upset, fast heart rate and shakiness.
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Who Should Not Take This Medication
Do not take this medication if you:
- are allergic or sensitive to ibuprofen, pseudoephedrine, or any ingredients of the medication
- are allergic to other NSAIDs or ASA
- are about to have or have just had heart surgery
- are dehydrated due to vomiting, diarrhea, or not drinking enough fluids
- are taking another NSAID
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Advil Cold & Sinus Liqui Gels
For over 20 years, people have trusted Advil Cold & Sinus for powerful, non-drowsy relief of their tough cold and sinus symptoms.
Many people attribute sinus pressure to an increase in mucus which blocks their airways. While it is true that increased mucus is a symptom of the common cold, it is not always what makes you feel so stuffed up. Sinus congestion can also be associated with the swelling of the tissues in the nose known as inflammation. The result is a shrinking of your airways.
Advil Cold & Sinus combines the relief of a strong decongestant to open your airways with the power of Advil to relieve the pain commonly associated with sinus pressure.
Temporarily relieves these symptoms associated with the common cold or flu:
- headache
- minor body aches & pains
12 years of age and older:
- 1 caplet/liquid-gel every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet/liquid-gel, 2 may be used.
- Do not use more than 6 caplets/liquid-gels in 24 hours unless directed by a doctor.
Under 12 years of age:
- Do not take
- Solubilized ibuprofen equal to 200mg ibuprofen *
- Pseudoephedrine HCI 30 mg
*Nonsteroidal anti-inflammatory drug
Inactive Ingredients:
- D& C yellow no. 10, FD& C red no. 40, fractionated coconut oil, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol
Use as directed. Read complete warnings and information.
How To Take Ibuprofen And Pseudoephedrine
Use Ibuprofen And Pseudoephedrine exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Use exactly as directed on the label, or as prescribed by your doctor. An overdose of ibuprofen can damage your stomach or intestines.
Take this medicine with food or milk to lessen stomach upset.
If you need surgery, tell the surgeon ahead of time if you have taken this medicine within the past few days.
Store at room temperature away from moisture and heat.
Since this medicine is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.
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