IBUPROFEN JUNIOR- ibuprofen tablet, chewable 
Physicians Total Care, Inc.

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Amerisource Bergen Junior Strength Ibuprofen Tablets, 100 mg Drug Facts

Active ingredient (in each tablet)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

Warnings

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

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 your child:

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

  • mouth or throat burning may occur; give with food or water
  • 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
  • the child does not get any relief within the 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. (1-800-222-1222)

Directions

Dosing Chart
Weight (lb)Age (yr)Tablets
under 24under 2ask a doctor
24-352-31
36-474-51 ½
48-596-82
60-719-102 ½
72-95113

Other information

Inactive ingredients

acesulfame potassium, ammonium glycerrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions or comments?

1-800-719-9260

Principal Display Panel

junior strength Ibuprofen tablets, 100 mg

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

NDC 54868-5623-0
24 chewable tablets

image of package label


Compare to Motrin® Junior Strength active ingredient

See New Warnings Information

FOR AGES 2 TO 11






Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146
IBUPROFEN  JUNIOR
ibuprofen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5623(NDC:24385-546)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SOYBEAN OIL (UNII: 241ATL177A)  
SUCCINIC ACID (UNII: AB6MNQ6J6L)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
Product Characteristics
ColorORANGEScore2 pieces
ShapeROUNDSize13mm
FlavorORANGEImprint Code L461
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5623-01 in 1 CARTON
124 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07635910/16/2007
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 5/2012
Document Id: a325acae-9aca-40b7-92f9-73e7b35a90cd
Set id: 4de8b851-adce-443e-a3a1-62a887b8dd96
Version: 1
Effective Time: 20120502
 
Physicians Total Care, Inc.