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Advil Junior Strength: Package Insert / Prescribing Info

Package insert / product label
Generic name: ibuprofen
Dosage form: tablet, coated
Drug class: Nonsteroidal anti-inflammatory drugs

Medically reviewed by Drugs.com. Last updated on Apr 24, 2024.

ACTIVE INGREDIENT (IN EACH TABLET)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Fever reducer/Pain reliever

Indications and Usage for Advil Junior Strength

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

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.

Advil Junior Strength Dosage and Administration

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

Junior Strength
Advil®

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

Fever
Aches & Pains

Lasts Up To
8
Hours

for ages 6-11 years

24 COATED
TABLETS

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Carton
JUNIOR STRENGTH ADVIL
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0175
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg
Inactive Ingredients
Ingredient NameStrength
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
METHYLPARABEN (UNII: A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
ColorBROWN (tan) Scoreno score
ShapeROUND (round tablet) Size8mm
FlavorImprint CodeAdvil;100
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0175-111 in 1 CARTON06/21/2011
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02026706/21/2011
Labeler - Haleon US Holdings LLC (079944263)

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