IBUPROFEN - ibuprofen tablet 
MARKSANS PHARMA LIMITED

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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)

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 you:
• are age 60 or older
• have had 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 
• take more or for a longer time than directed


Heart attack and stroke warning: NSAIDs, except aspirin, increase 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


Ask a doctor before use if



  

Ask a doctor or pharmacist before use if

When using this product


Stop use and ask doctor if


If pregnant or breast-feeding


ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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


         

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



Other information

Inactive ingredient(s)


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


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

NDC 25000-136-03, Ibuprofen Tablets, USP 200mg


30 counts Bottle Label




ibu-tab-30ct-bot-label


NDC 25000-136-03,Ibuprofen Tablets, USP 200mg


30 counts Carton Label



ibu-tab-30ct-cart-label


NDC 25000-135-03, Ibuprofen Tablets, USP 200mg (Caplets)


30 counts Bottle Label




ibu-cap-30ct-bot-label


NDC 25000-135-03, Ibuprofen Tablets, USP 200mg (Caplets)


30 counts Carton Label



ibu-cap-30ct-cart-label


NDC 25000-136-69, Ibuprofen Tablets, USP 200mg


300 counts Bottle Label



ibu-tab-300ct-bottle-label


NDC 25000-136-14, Ibuprofen Tablets, USP 200mg


1000 counts Bottle Label



ibu-tab-1000ct-bot-label


NDC 25000-136-71, Ibuprofen Tablets, USP 200mg


1000 counts (PET) Bottle Label


ibu-tab-1000ct-pet-bottle-label


NDC 25000-135-14, Ibuprofen Tablets, USP 200mg (Caplets)


1000 counts Bottle Label


ibu-cap-1000ct-bot-label


NDC 25000-135-70, Ibuprofen Tablets, USP 200mg (Caplets)


500 counts Bottle Label


ibu-cap-500ct-bottle-label


NDC 25000-136-02, Ibuprofen Tablets, USP 200mg


24 counts Bottle Label


ibu-tab-24ct-bot-label


NDC 25000-136-02, Ibuprofen Tablets, USP 200mg


24 counts Carton Label


ibu-tab-24ct-cart-label


NDC 25000-135-02, Ibuprofen Tablets, USP 200mg (Caplets)


24 counts Bottle Label


ibu-cap-24ct-bot-label


NDC 25000-135-02, Ibuprofen Tablets, USP 200mg (Caplets)


24 counts Carton Label


ibu-cap-24ct-cart-label

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-135
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULE (Capsule Shaped) Size10mm
FlavorImprint Code 120
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-135-0330 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
2NDC:25000-135-141000 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
3NDC:25000-135-306 in 1 BOX11/06/2015
36500 in 1 BAG; Type 0: Not a Combination Product
4NDC:25000-135-981 in 1 BOX11/06/2015
434065 in 1 BAG; Type 0: Not a Combination Product
5NDC:25000-135-931 in 1 BOX11/06/2015
537470 in 1 BAG; Type 0: Not a Combination Product
6NDC:25000-135-70500 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
7NDC:25000-135-021 in 1 CARTON12/20/2019
724 in 1 BOTTLE; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUND (Round Shaped) Size15mm
FlavorImprint Code 115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-136-0330 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
2NDC:25000-136-141000 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
3NDC:25000-136-306 in 1 BOX11/06/2015
36500 in 1 BAG; Type 0: Not a Combination Product
4NDC:25000-136-981 in 1 BOX11/06/2015
434065 in 1 BAG; Type 0: Not a Combination Product
5NDC:25000-136-931 in 1 BOX11/06/2015
537470 in 1 BAG; Type 0: Not a Combination Product
6NDC:25000-136-69300 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
7NDC:25000-136-711000 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
8NDC:25000-136-021 in 1 CARTON12/20/2019
824 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123711/06/2015
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-135, 25000-136)

Revised: 12/2021
Document Id: e0bdfb43-8e4d-4ff4-9642-f3bd460b8465
Set id: 859d7190-586f-4766-a7e7-9e800a72d58b
Version: 7
Effective Time: 20211221
 
MARKSANS PHARMA LIMITED