JUNIOR STRENGTH ADVIL description, usages, side effects, indications, overdosage, supplying and lots more!

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JUNIOR STRENGTH ADVIL

Pfizer Consumer Healthcare

Junior Strength Advil (Ibuprofen) Chewables


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

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

WARNINGS

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

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, or asthma
  • 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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 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 lb under 6 yr ask a doctor
48-59 lb 6-8 yr 2 tablets
60-71 lb 9-10 yr 2 1/2 tablets
72-95 lb 11yr 3 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 Chewable Tablet Bottle Label

Junior Strength
Advil®

Fever Reducer/
Pain Reliever (NSAID)

READ AND KEEP CARTON FOR
COMPLETE WARNINGS AND
INFORMATION

Grape Flavor
24 CHEWABLE TABLETS

Pfizer, Madison, NJ 07940 USA
© 2011 Pfizer Inc. Made in Canada

JUNIOR STRENGTH ADVIL

PRINCIPAL DISPLAY PANEL - 24 Chewable Tablet Carton

Junior Strength
Advil®
Chewables

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

Fever
Aches & Pains
Lasts Up To
8
Hours

Grape-Flavored Chewables
for ages 6-11 years

24
CHEWABLE
TABLETS

JUNIOR STRENGTH ADVIL

JUNIOR STRENGTH ADVIL

ibuprofen TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-0179
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 100 mg

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
CELLACEFATE
SILICON DIOXIDE
D&C RED NO. 30
FD&C BLUE NO. 2
GELATIN
MAGNESIUM STEARATE
mannitol
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
PURPLE (light purple) 10 mm Advil;100 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 NDC:0573-0179-20 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020944 2011-06-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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