Ibuprofen Junior

Dosage form: tablet, chewable
Ingredients: IBUPROFEN 100mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-5623

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:

  • 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 your 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 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
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day
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
  • phenylketonurics: contains phenylalanine 6 mg per tablet
  • do not use if printed seal under cap is broken or missing
  • store at 20-25°C (68-77°F)
  • see end panel for lot number and expiration date

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



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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MANNITOL 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
SOYBEAN OIL 
SUCCINIC ACID 
ACESULFAME POTASSIUM 
Product Characteristics
ColorORANGEScore2 pieces
ShapeROUNDSize13mm
FlavorORANGEImprint CodeL461
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-5623-01 BOTTLE (BOTTLE) in 1 CARTON
124 TABLET, CHEWABLE (TABLET) 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/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 05/2012
 
Physicians Total Care, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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