FLEX-PRIN- ibuprofen tablet

Flex-Prin by

Drug Labeling and Warnings

Flex-Prin by is a Otc medication manufactured, distributed, or labeled by Provision Medical Products, Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN. In

case of overdose, get medical help or

contact a Poison Control Center right

away.

WARNINGS

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

ACTIVE INGREDIENT-IBUPROFEN 200 MG

PURPOSE

PAIN RELIEVER/FEVER REDUCER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEX-PRIN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-2525
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	IBU200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-2525-5	250 in 1 CARTON	04/05/2015
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 69103-2525-6	100 in 1 CARTON	04/05/2015
2		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079129	03/31/2015

Labeler - Provision Medical Products (036936831)

Registrant - Provision Medical Products (036936831)

Establishment
Name	Address	ID/FEI	Business Operations
Ultraseal Corporation		085752004	pack(69103-2525)

Establishment
Name	Address	ID/FEI	Business Operations
SHASUN PHARMACEUTICALS LIMITED		915786829	manufacture(69103-2525)