NDC | 52605-114-01, 52605-114-10, 52605-117-01 |
Set ID | 00bc1e01-f90e-444d-b7d6-807797a1d136 |
Category | Human OTC Drug Label |
Packager | Polygen Pharmaceuticals LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA091239 |
- Active ingredient(s)
- Purpose
- Use(s)
-
Warnings
Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include:
- asthma (wheezing)
- blisters
- facial swelling
- hives
- rash
- shock
- skin reddening
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause 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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- the more or for a longer time than directed
- Do not use
-
Ask a doctor before use if
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems such as heartburn
- the stomach bleeding warning applies to you
- you have high blood pressure, heart disease , kidney disease, liver cirrhosis
- you are taking a diuretic
- you have asthma
- Ask a doctor or pharmacist before use if
- When using this product
-
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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms occur
Side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088
- Pregnancy/Breastfeeding
- Keep out of reach of children
-
Directions
- do not take more than directed
- the smallest effective dose should be used
adults and children
12 years and older:· take 1 tablet every 4 to 6 hours while symptoms persist
· if pain or fever does not respond to 1 tablet, 2 tablets may be used
· do not exceed 6 tablets in 24 hours unless directed by a doctorchildren under 12 years: ask a doctor - other information
- Inactive ingredient
- Storage
- Questions
-
Principal Display Panel
CARTON LABEL PDP
NDC: 52605-114-01
Compare to the active ingredient in Advil®
IBUPROFEN TABLETS, USP 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED TABLETS
SEE NEW WARNINGS INFORMATION
BOTTLE LABEL PDP
NDC: 52605-114-01
IBUPROFEN TABLETS, USP 200 mg
PAIN RELIEVER/ FEVER REDUCER(NSAID)
100 COATED TABLETS
SEE NEW WARNINGS INFORMATION
CARTON LABEL PDP
NDC: 52605-117-01
Compare to the active ingredient in Advil®
IBUPROFEN TABLETS, USP 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED CAPLETS
SEE NEW WARNINGS INFORMATION
BOTTLE LABEL PDP
NDC: 52605-117-01
IBUPROFEN TABLETS, USP 200 mg
PAIN RELIEVER/ FEVER REDUCER(NSAID)
100 COATED CAPLETS
SEE NEW WARNINGS INFORMATION
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52605-114 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) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) POLYVINYL ALCOHOL (UNII: 532B59J990) Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code 114 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52605-114-01 1 in 1 CARTON 1 100 in 1 BOTTLE 2 NDC:52605-114-10 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 06/05/2012 IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52605-117 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) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) POLYVINYL ALCOHOL (UNII: 532B59J990) Product Characteristics Color BROWN Score no score Shape CAPSULE Size 15mm Flavor Imprint Code 117 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52605-117-01 1 in 1 CARTON 1 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 06/05/2012 Labeler - Polygen Pharmaceuticals LLC (962415720) Registrant - Polygen Pharmaceuticals LLC (962415720) Establishment Name Address ID/FEI Business Operations Marksans Pharma Limited 925822975 MANUFACTURE(52605-117)