Monday, July 30, 2012

Topcare Ibuprofen Junior Strength Chewable




Generic Name: ibuprofen

Dosage Form: tablet, chewable
Topco 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 chances are 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


  • child has problems or serious side effects from taking pain relievers or fever reducers

  • stomach bleeding warning applies to your child

  • child has a history of stomach problems, such as heartburn

  • 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

  • do not give longer than 10 days, unless directed by a doctor (see Warnings)

  • 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, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, flavors, hypromellose, magnasweet 180, magnesium stearate, mannitol, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid, whey protein concentrate



Questions or comments?


1-888-423-0139



Principal Display Panel


See New Warnings Information


For Ages 2 to 11


Junior Strength


Ibuprofen Tablets 100 mg


Pain Reliever/Fever Reducer (NSAID)


Lasts Up to 8 Hours


Actual Size


Compare to Motrin® Junior Strength active ingredient


Ibuprofen Tablets 100 mg Carton










TOPCARE IBUPROFEN  JUNIOR STRENGTH
ibuprofen  tablet, chewable










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)36800-461
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN)IBUPROFEN100 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorORANGEScore2 pieces
ShapeROUNDSize13mm
FlavorORANGEImprint CodeL461
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
136800-461-621 BOTTLE In 1 CARTONcontains a BOTTLE
124 TABLET In 1 BOTTLEThis package is contained within the CARTON (36800-461-62)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07635905/28/2004


Labeler - Topco Associates LLC (006935977)
Revised: 07/2009Topco Associates LLC




More Topcare Ibuprofen Junior Strength Chewable resources


  • Topcare Ibuprofen Junior Strength Chewable Side Effects (in more detail)
  • Topcare Ibuprofen Junior Strength Chewable Dosage
  • Topcare Ibuprofen Junior Strength Chewable Use in Pregnancy & Breastfeeding
  • Drug Images
  • Topcare Ibuprofen Junior Strength Chewable Drug Interactions
  • Topcare Ibuprofen Junior Strength Chewable Support Group
  • 51 Reviews for Topcare Ibuprofen Junior Strength Chewable - Add your own review/rating


Compare Topcare Ibuprofen Junior Strength Chewable with other medications


  • Aseptic Necrosis
  • Back Pain
  • Costochondritis
  • Cystic Fibrosis
  • Diffuse Idiopathic Skeletal Hyperostosis
  • Dysautonomia
  • Fever
  • Frozen Shoulder
  • Gout, Acute
  • Headache
  • Muscle Pain
  • Osteoarthritis
  • Pain
  • Patent Ductus Arteriosus
  • Period Pain
  • Rheumatoid Arthritis
  • Sciatica
  • Spondylolisthesis
  • Temporomandibular Joint Disorder

No comments:

Post a Comment