IBUPROFEN - ibuprofen tablet 
MARKSANS PHARMA LIMITED

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

Active ingredient(s)


Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug

Purpose


Pain reliever / fever reducer

Use(s)


temporarily relieves minor aches and pains due to :

temporarily reduces fever

Warnings

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


If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Heart attack and stroke warning: NSAID's 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

• 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, kidney disease, asthma, or had a stroke
• you are taking a diuretic


Ask a doctor or pharmacist before use if you are


When using this product


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 problems 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 the painful area
any new symptoms appear


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 ingredients

colloidal silicon dioxide, croscarmellose sodium, iron oxide red, 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 Industrial Estate
Verna, Goa-403722, India  


Storage

Principal Display Panel

NDC 25000-114-03, Ibuprofen Tablets USP, 200mg


30 counts Bottle Label



ibu-tab-30ct-bottle-label




NDC 25000-114-03, Ibuprofen Tablets USP, 200mg


30 counts Carton Label


ibu-tab-30ct-cart-label




NDC 25000-117-03, Ibuprofen Tablets USP, 200mg (Caplets)


30 counts Bottle Label



ibu-cap-30ct-bottle-label


NDC 25000-117-03, Ibuprofen Tablets USP, 200mg (Caplets)


30 counts Carton Label


ibu-cap-30ct-cart-label


NDC 25000-114-70, Ibuprofen Tablets USP, 200mg


500 counts Bottle Label



ibu-tab-500ct-bottle-label


NDC 25000-114-14, Ibuprofen Tablets USP, 200mg


1000 counts Bottle Label



ibu-tab-1000ct-bottle-label


NDC 25000-114-71, Ibuprofen Tablets USP, 200mg


1000 counts (PET)  Bottle Label


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


NDC 25000-117-14, Ibuprofen Tablets USP, 200mg


1000 counts Bottle Label (Caplets)


ibu-cap-1000ct-bottle-label


NDC 25000-117-69, Ibuprofen Tablets USP, 200mg (Caplets)


300 counts Bottle Label


ibu-tab-300ct-bottle-label


NDC 25000-114-02, Ibuprofen Tablets USP, 200mg


24 counts Bottle Label


ibu-tab-24ct-bottle-label


NDC 25000-114-02, Ibuprofen Tablets USP, 200mg


24 counts Carton Label


ibu-tab-24ct-cart-label


NDC 25000-117-02, Ibuprofen Tablets USP, 200mg (Caplets)


24 counts Bottle Label


ibu-cap-24ct-bottle-label


NDC 25000-117-02, 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:25000-114
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-114-0330 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
2NDC:25000-114-141000 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
3NDC:25000-114-204 in 1 BOX07/25/2011
36500 in 1 BAG; Type 0: Not a Combination Product
4NDC:25000-114-306 in 1 BOX07/25/2011
46500 in 1 BAG; Type 0: Not a Combination Product
5NDC:25000-114-981 in 1 BOX07/25/2011
534065 in 1 BAG; Type 0: Not a Combination Product
6NDC:25000-114-931 in 1 BOX07/25/2011
637470 in 1 BAG; Type 0: Not a Combination Product
7NDC:25000-114-70500 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
8NDC:25000-114-711000 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
9NDC:25000-114-021 in 1 CARTON12/20/2019
924 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123907/25/2011
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-117
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code 117
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-117-0330 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
2NDC:25000-117-141000 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
3NDC:25000-117-204 in 1 BOX07/25/2011
36500 in 1 BAG; Type 0: Not a Combination Product
4NDC:25000-117-306 in 1 BOX07/25/2011
46500 in 1 BAG; Type 0: Not a Combination Product
5NDC:25000-117-981 in 1 BOX07/25/2011
534065 in 1 BAG; Type 0: Not a Combination Product
6NDC:25000-117-931 in 1 BOX07/25/2011
637470 in 1 BAG; Type 0: Not a Combination Product
7NDC:25000-117-69300 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
8NDC:25000-117-021 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
ANDAANDA09123907/25/2011
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975LABEL(25000-117) , MANUFACTURE(25000-114, 25000-117)

Revised: 12/2021
Document Id: 1bdc2c02-575f-4b55-ad66-47108f628d18
Set id: 3c8df1e5-61bc-4e70-b6b9-8973986ad589
Version: 8
Effective Time: 20211221
 
MARKSANS PHARMA LIMITED