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) Tablets


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
48-71 lb 6-10 yr 2 tablets
72-95 lb 11 yr 3 tablets

OTHER INFORMATION

  • one dose lasts 6-8 hours
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • see side of box for lot number and expiration date

INACTIVE INGREDIENTS

acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide

QUESTIONS OR COMMENTS?

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

PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Label

Ages 6-11
Junior Strength
Advil
®
Fever Reducer / Pain Reliever (NSAID)

24 Coated Tablets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

JUNIOR STRENGTH ADVIL

PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton

Junior Strength
Advil
®

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

Actual Size

for ages 6–11years

Fever

Aches & Pains

Lasts Up To
8
Hours

24 COATED
TABLETS

JUNIOR STRENGTH ADVIL

JUNIOR STRENGTH ADVIL

ibuprofen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-0175
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
carnauba wax
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
METHYLPARABEN
cellulose, microcrystalline
SHELLAC
POVIDONES
PROPYLPARABEN
SODIUM BENZOATE
STEARIC ACID
SUCROSE
titanium dioxide
DIACETYLATED MONOGLYCERIDES

Product Characteristics

Color Size Imprint Code Shape
BROWN (tan) 8 mm Advil;100 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 NDC:0573-0175-11 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020267 2011-06-21


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