Label: FLEX-PRIN- ibuprofen tablet
- NDC Code(s): 69103-2525-5, 69103-2525-6
- Packager: Provision Medical Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 5, 2023
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- INDICATIONS & USAGE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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
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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
- ACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLEX-PRIN
ibuprofen tabletProduct 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 Granules India Limited 860316511 manufacture(69103-2525)