Ibuprofen description, usages, side effects, indications, overdosage, supplying and lots more!

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Ibuprofen

MARKSANS PHARMA LIMITED

Ibuprofen Tablets 200mg (OTC; Brown Tablets & Caplets)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)


Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug

Purpose


Pain reliever / fever reducer

Use(s)


  • temporarily relieves minor aches and pain due to :
  • backache
  • headache
  • menstrual cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever

Warnings

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

  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • skin reddening


Stomach bleeding warning:
  • are age 60 or older
  • have bad stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • the more or for a longer time than directed

Do not use


  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if


 you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretics
  • reached age 60 or older

Ask a doctor or pharmacist before use if


you are

  • taking any other drugs containg an NSAID (prescription or nonprescription)
  • taking a blood thining (anticoagulant) or steriod drug
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attacks or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product


  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke

Stop use and ask doctor if


  • you feel faint, vomit blood, or have bloody or black stools.

        These are signs of stomach bleeding.

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in painful area
  • any new symptoms appear

Pregnancy/Breastfeeding


ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause a problems in the unborn child or complications during delivery.

Keep out of reach of children


In case of overdose, get medical help or contact a PoisonControlCenter right away. (1-800-222-1222)

Directions


  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a docter
    (see Wanings)

 

adults and children 12 years and older
  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor.
Children under 12 years
  • ask a doctor

Ibuprofen Other information


  • store between 20-25 0c (68-77 0 F).
  • do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing.

Inactive ingredients


colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, titanium dioxide.

 

Manufactured for:

Marksans Pharma Inc.

Lake Grove, NY11755, USA

 

Manufactured by:

Marksans Pharma Ltd.

Verna, Goa-403722, India

 

Mfg. Lic. No. GO/ Drugs/515

Principal Display Panel

PRINICPAL DISPLAY PANEL IBUPROFEN TABLETS 200 mg -







Ibuprofen





Ibuprofen

Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:25000-114
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ferric oxide red
MAGNESIUM STEARATE
cellulose, microcrystalline
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BROWN 10 mm 114 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:25000-114-03 30 in 1 BOTTLE
2 NDC:25000-114-14 1000 in 1 BOTTLE
3 6500 in 1 BAG
4 6500 in 1 BAG
5 NDC:25000-114-30 6 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091239 2011-07-25


Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:25000-117
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ferric oxide red
MAGNESIUM STEARATE
cellulose, microcrystalline
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BROWN 15 mm 117 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:25000-117-03 30 in 1 BOTTLE
2 NDC:25000-117-14 1000 in 1 BOTTLE
3 6500 in 1 BAG
4 6500 in 1 BAG
5 NDC:25000-117-30 6 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091239 2011-07-25


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