FLEX-PRIN- ibuprofen tablet 
Provision Medical Products

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

If pregnant or breast-feeding, ask a health

professional before use. It is especially important not to

use Ibuprofen during the last 3 months of pregnancy

unless 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.

Warnings:

Allergy Alert: Ibuprofen may cause a severe allergic

reaction which may include:

• hives • shock • facial swelling • asthma (wheezing)

Alcohol Warning: If you consume 3 or more alcoholic

drinks every day, ask your doctor whether you should

take Ibuprofen or other pain relievers/ fever reducers.

Ibuprofen may cause stomach bleeding.

Do not use:

• if you have ever had an allergic reaction to any

other pain reliever/fever reducer

Ask a doctor before use if you have:

• stomach pain

• problems or serious side eects from taking

pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are:

• under a doctor's care for any serious condition

• taking any other drug

• taking any other product that contains Ibuprofen,

or any other pain reliever/fever reducer

When using this product give with food or milk if

stomach upset occurs.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right

away • 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

• any new symptoms appear • redness or swelling is

present in the painful area

Directions:

• Do not take more than directed.

Adults and children 12 years and older

• Take 1  tablet every 4 to 6  hours while symptoms

• If pain or fever does not respond to 1 tablet, 2 tablets may be used.

Do not exceed 6 tablets in 24 hours, unless as directed by a doctor.

• The smallest effective dose should be used.

Children under 12 year

• Ask a doctor.

Inactive Ingredients:

carnauba wax, croscarmellose sodium,

hydroxypropyl methylcellulose,

microcrystalline cellulose,

polyethylene glycol, polysorbate 80,

povidone, pregelatinized starch, silicon

dioxide, sodium starch glycolate,

stearic acid and titanium dioxide.

ACTIVE INGREDIENT-IBUPROFEN 200 MG

PAIN RELIEVER/FEVER REDUCER

FLEX PRIN BOX

FLEX-PRIN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2525
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-2525-5250 in 1 CARTON04/05/2015
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:69103-2525-6100 in 1 CARTON04/05/2015
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912903/31/2015
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited860316511manufacture(69103-2525)

Revised: 1/2023
Document Id: f18ebbe5-cd44-8c27-e053-2a95a90ab79b
Set id: c01538b0-ca4c-434a-be8f-fe023deb84e1
Version: 3
Effective Time: 20230105
 
Provision Medical Products