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Ibuprofen by MARKSANS PHARMA LIMITED

Medically reviewed on May 3, 2018

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: MARKSANS PHARMA LIMITED
NDC Code: 25000-135

Ibuprofen Tablets 200mg (Orange-Round and Capsule shaped) 

Active ingredient(s)  

Ibuprofen 200 mg (NSAID)*

  * nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever/fever reducer

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

Warnings

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

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

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 you:

  • are age 60 or older
  • have bad stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (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
  •  Heart attack and stroke warning: NSAID's except aspirin, increases 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.  

Do not use
  • if you have ever had an allergic reaction to ibuprofen or or 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
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn 
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease, asthma, or had a stroke. 
  • you are taking a diuretic

  

Ask a doctor or pharmacist before use if

You are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • 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 doctor if
  • you experience any of the following signs of stomach bleeding      
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • You have symptoms of heart problem  or stroke:
    • Chest pain
    • Trouble breathing
    • Weakness in one part or side of body
    • Slurred speech
    • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in painful area
  • any new symptoms appear

Other required warnings

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 Poison Control Center right away. (1-800-222-1222)

Directions
  • do not take more than directed
  • the smallest effective dose should be used

         

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



Inactive ingredient(s)

Silicon dioxide, croscarmellose sodium, FD & C yellow # 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.

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


Questions or comments?

Call 1-877-290-4008


Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA



Manufactured by:

Marksans Pharma Ltd.


Plot No. L-82, L-83,
Verna Indl. Estate,
Verna, Goa-403 722, India.

Principal Display Panel

Ibuprofen Tablets, USP 200mg


30 counts
Bottle Label








Ibuprofen Tablets, USP 200mg


30 counts
Carton Label

   





Ibuprofen Tablets, USP 200mg (Caplets)


30 counts
Bottle Label












Ibuprofen Tablets, USP 200mg (Caplets)


30 counts
Carton Label







IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-135
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
STARCH, PREGELATINIZED CORN 
TALC 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOL 3350 
FD&C YELLOW NO. 6 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULE (Capsule Shaped) Size10mm
FlavorImprint Code120
Contains    
Packaging
#Item CodePackage Description
1NDC:25000-135-0330 TABLET in 1 BOTTLE
2NDC:25000-135-141000 TABLET in 1 BOTTLE
3NDC:25000-135-306 BAG in 1 BOX
36500 TABLET in 1 BAG
4NDC:25000-135-981 BAG in 1 BOX
434065 TABLET in 1 BAG
5NDC:25000-135-931 BAG in 1 BOX
537470 TABLET in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123711/06/2015
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-136
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
STARCH, PREGELATINIZED CORN 
TALC 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOL 3350 
FD&C YELLOW NO. 6 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUND (Round Shaped) Size15mm
FlavorImprint Code115
Contains    
Packaging
#Item CodePackage Description
1NDC:25000-136-0330 TABLET in 1 BOTTLE
2NDC:25000-136-141000 TABLET in 1 BOTTLE
3NDC:25000-136-306 BAG in 1 BOX
36500 TABLET in 1 BAG
4NDC:25000-136-981 BAG in 1 BOX
434065 TABLET in 1 BAG
5NDC:25000-136-931 BAG in 1 BOX
537470 TABLET in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123711/06/2015
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIOperations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-135, 25000-136)

 
MARKSANS PHARMA LIMITED

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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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