NDC | 57896-941-01, 57896-941-05, 57896-941-10, 57896-941-20, 57896-941-25, 57896-941-50 |
Set ID | 0744c3ca-4224-4f6a-a033-880949b544fd |
Category | HUMAN OTC DRUG LABEL |
Packager | Geri-Care Pharmaceutical Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA075010 |
- Active ingredient (in each brown tablet)
- Purpose
- Uses
-
Warnings
Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- shock
- hives
- facial swelling
- asthma (wheezing)
- skin reddening
- rash
- blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning:This product contains an NSAID, 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 or asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- 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 a 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 - leg swelling
- slurred speech - weakness in one part or side of body - pain gets worse or lasts more than 10 days
- redness or swelling is present in the painful area
- fever gets worse or lasts more than 3 days
- any new symptoms occur
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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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Directions
- do not use more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: 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 take more than 6 tablets in 24 hours unless directed by a doctor
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Package label
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-941 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 STARCH, CORN (UNII: O8232NY3SJ) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FERRIC OXIDE RED (UNII: 1K09F3G675) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code 44291 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-941-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2017 2 NDC:57896-941-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2017 3 NDC:57896-941-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2017 4 NDC:57896-941-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2017 5 NDC:57896-941-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2017 6 NDC:57896-941-20 1 in 1 CARTON 02/01/2012 6 200 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075010 01/01/2004 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)