IBUPROFEN - ibuprofen capsule, liquid filled 
MARKSANS PHARMA LIMITED

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Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug


Purpose

Pain reliever/Fever reducer

Uses

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


Warnings

Allergy alert: Ibuprofen may cause a severe allergic 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 NSAID, which may cause severe stomach bleeding. The chance is higher if you

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 you are

When using this product

Stop use and ask a 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 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.

Directions

Other information

• each capsule contains: potassium 20 mg
• read all warnings and directions before use. Keep carton.
• store at 20-25ºC (68-77ºF)
• avoid excessive heat above 40°C (104°F).

Inactive ingredients

ammonium hydroxide, FD&C Green No. 3, gelatin, iron oxide black, medium-chain triglycerides, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, shellac, sorbitan monooleate, sorbitol sorbitan


Questions or comments?

call toll free 1-877-376-4271

PRINCIPAL DISPLAY PANEL

 Ibuprofen capsules 200 mg (Liquid Filled Capsules)


NDC 25000-133-43

Ibuprofen capsules 200 mg (Liquid filled capsules)
10's count bottle label


ibu-sgc-10's-label


NDC 25000-133-43

Ibuprofen capsules 200 mg (Liquid filled capsules)
10's count carton label


ibu-sgc-10's-ifc


NDC 25000-133-01

Ibuprofen capsules 200 mg (Liquid filled capsules)
20's count bottle label


ibu-sgc-20's-label


NDC 25000-133-01

Ibuprofen capsules 200 mg (Liquid filled capsules)
20's count carton label


ibu-sgc-20's-ifc


NDC 25000-133-04

Ibuprofen capsules 200 mg (Liquid filled capsules)
32's count bottle label


ibu-sgc-32s-bott-labl


NDC 25000-133-04

Ibuprofen capsules 200 mg (Liquid filled capsules)
32's count carton label


ibu-sgc-32s-cart-labl


NDC 25000-133-69

Ibuprofen capsules 200 mg (Liquid filled capsules)
300's count bottle label


ibu-sgc-300s-bott-labl


NDC 25000-133-13

Ibuprofen capsules 200 mg (Liquid filled capsules)
600's count bottle label


ibu-sgc-600s-bott-labl


Ibuprofen capsules 200 mg (Mini liquid filled capsules)

 

NDC 25000-062-43

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
10's count bottle label


ibu-sgc-ibumini-10s-bott-labl


NDC 25000-062-43

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
10's count carton label


ibu-sgc-ibumini-10s-cart-labl

 

NDC 25000-062-01

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
20's count bottle label


ibu-sgc-ibumini-20s-bott-labl


NDC 25000-062-01

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
20's count carton label


ibu-sgc-ibumini-20s-cart-labl


NDC 25000-062-04

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
32's count bottle label


ibu-sgc-ibumini-32s-bott-labl


NDC 25000-062-04

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
32's count carton label


ibu-sgc-ibumini-32s-cart-labl


NDC 25000-062-67

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
80's count bottle label


ibu-sgc-ibumini-80s-bott-labl


NDC 25000-062-67

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
80's count carton label


ibu-sgc-ibumini-80s-cart-labl


NDC 25000-062-69

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
300's count PET bottle label


ibu-sgc-ibumini-300s-petbott-labl


NDC 25000-062-13

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
600's count bottle label


ibu-sgc-ibumini-600s-bott-labl




 



IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
FERROUS OXIDE (UNII: G7036X8B5H)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 133
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-133-235 in 1 DRUM09/01/2017
12000 in 1 BAG; Type 0: Not a Combination Product
2NDC:25000-133-184 in 1 BOX09/01/2017
22500 in 1 BAG; Type 0: Not a Combination Product
3NDC:25000-133-041 in 1 CARTON09/01/2017
332 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:25000-133-131 in 1 BOX09/01/2017
4600 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:25000-133-431 in 1 CARTON09/01/2017
510 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:25000-133-011 in 1 CARTON09/01/2017
620 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:25000-133-69300 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920509/01/2017
IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-062
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
FERROUS OXIDE (UNII: G7036X8B5H)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize6mm
FlavorImprint Code 62
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-062-431 in 1 CARTON08/18/2020
110 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:25000-062-0101 in 1 CARTON08/18/2020
220 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:25000-062-041 in 1 CARTON08/18/2020
332 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:25000-062-671 in 1 CARTON08/18/2020
480 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:25000-062-13600 in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
6NDC:25000-062-871 in 1 BOX08/18/2020
62500 in 1 BAG; Type 0: Not a Combination Product
7NDC:25000-062-69300 in 1 BOTTLE; Type 0: Not a Combination Product11/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920508/18/2020
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-062, 25000-133)

Revised: 4/2023
Document Id: 009afd24-3f12-4208-876d-f22ce92a40ce
Set id: 403ec259-3be1-4e0b-ab7b-fee213b7eabe
Version: 11
Effective Time: 20230403
 
MARKSANS PHARMA LIMITED