FDA Label for Junior Strength Advil

View Indications, Usage & Precautions

Junior Strength Advil Product Label

The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Purpose



Fever reducer/Pain reliever


Uses



temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

Allergy Alert:



Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters
  • If an allergic reaction occurs, stop use and seek medical help right away.


Stomach Bleeding Warning:



This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the child

  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • takes more or for a longer time than directed

Heart Attack And Stroke Warning



NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.


Sore Throat Warning:



Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.


Do Not Use



  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask A Doctor Before Use If



  • stomach bleeding warning applies to the child
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • child has a history of stomach problems, such as heartburn
  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting or diarrhea
  • child is taking a diuretic

Ask A Doctor Or Pharmacist Before Use If The Child Is



  • under a doctor's care for any serious condition
  • taking any other drug

When Using This Product



  • take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If



  • child experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has stomach pain that does not get better
    • child has symptoms of heart problems or stroke:
      • chest pain
      • trouble breathing
      • weakness in one part or side of body
      • slurred speech
      • leg swelling
      • child does not get any relief within first day (24 hours) of treatment
      • fever or pain gets worse or lasts more than 3 days
      • redness or swelling is present in the painful area
      • any new symptoms appear

Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • repeat dose every 6-8 hours, if needed
  • do not use more than 4 times a day
  • Dosing Chart
    Weight (lb)Age (yr)Dose (tablets)
    under 48 lbunder 6 yrask a doctor
    48-59 lb6-8 yr2 tablets
    60-71 lb9-10 yr2 1/2 tablets
    72-95 lb11yr3 tablets

Other Information



  • Phenylketonurics: contains phenylalanine 4.2 mg per tablet
  • one dose lasts 6-8 hours
  • store at 20-25°C (68-77°F)
  • see side of box for lot number and expiration date

Inactive Ingredients



aspartame, cellacefate, colloidal silicon dioxide, D&C red no. 30 aluminum lake, FD&C blue no. 2 aluminum lake, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial flavors, sodium starch glycolate


Questions Or Comments?



call toll free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional

Made in Canada


Principal Display Panel - 24 Tablet Bottle Label



Junior Strength
Advil
®

Ibuprophen Tablets, 100 mg
Pain Reliever/
Fever Reducer (NSAID)

READ AND KEEP CARTON

Grape Flavor
24 CHEWABLE TABLETS

Pfizer, Madison, NJ 07940 USA
© 2016 Pfizer Inc.


Principal Display Panel - 24 Tablet Bottle Carton



Junior Strength
Advil
®
Chewables
Ibuprofen Tablets, 100 mg Pain Reliever/Fever Reducer (NSAID)

Fever

Aches & Pains

Lasts Up To
8
Hours

Grape-Flavored Chewables
for ages 6-11 years

24
CHEWABLE
TABLETS


* Please review the disclaimer below.