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Ibuprofen by MARKSANS PHARMA LIMITED

Medically reviewed on September 1, 2017

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg
Labeler: MARKSANS PHARMA LIMITED
NDC Code: 25000-133

ACTIVE INGREDIENT(S)

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


PURPOSE

Pain reliever/Fever reducer

*nonsteroidal anti-inflammatory drug

USE(S)
  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • 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:

  • 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 nonsteroidal anti - inflammatory drug (NSAIDs), 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
  • 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
  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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
  • under a doctor's care for any serious condition
  • taking aspirin for heart attack 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

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 of the body
  •  slurred speech
  •  leg swelling
  • 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 the painful area
  • any new symptoms appear

OTHER REQUIRED WARNINGS
  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton.

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 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
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 capsule, 2 capsules may be used
  • do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

INACTIVE INGREDIENTS

Ammonium Hydroxide, FD&C Green No. 3, Gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol sorbitan, Sorbitan monooleate.

Questions or comments

Call toll free 1-877-376-4271

STORAGE
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

PRINCIPAL DISPLAY PANEL

Ibuprofen capsules, 200mg
(Liquid filled capsules)
10's bottle label
NDC 25000-133-43




10's carton label
NDC 25000-133-43




20's bottle label
NDC 25000-133-01



20's carton label
NDC 25000-133-01




32's bottle label
NDC 25000-133-04





32's carton label
NDC 25000-133-04




600 Softgels 
NDC 25000-133-13






IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-133
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA 
FD&C GREEN NO. 3 
GELATIN 
SORBITOL 
WATER 
SHELLAC 
SORBITAN MONOOLEATE 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
POTASSIUM HYDROXIDE 
FERROUS OXIDE 
MEDIUM-CHAIN TRIGLYCERIDES 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code133
Contains    
Packaging
#Item CodePackage Description
1NDC:25000-133-235 BAG in 1 DRUM
12000 CAPSULE, LIQUID FILLED in 1 BAG
2NDC:25000-133-184 BAG in 1 BOX
22500 CAPSULE, LIQUID FILLED in 1 BAG
3NDC:25000-133-041 BOTTLE in 1 CARTON
332 CAPSULE, LIQUID FILLED in 1 BOTTLE
4NDC:25000-133-131 BOTTLE in 1 BOX
4600 CAPSULE, LIQUID FILLED in 1 BOTTLE
5NDC:25000-133-431 BOTTLE in 1 CARTON
510 CAPSULE, LIQUID FILLED in 1 BOTTLE
6NDC:25000-133-011 BOTTLE in 1 CARTON
620 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920509/01/2017
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIOperations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-133)

 
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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