NDC | 53746-140-01, 53746-140-10, 53746-140-24, 53746-143-01, 53746-143-10, 53746-143-24 |
Set ID | ee241be0-35f8-4789-a71f-98de31d6a590 |
Category | HUMAN OTC DRUG LABEL |
Packager | Amneal Pharmaceuticals of New York LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA071333 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS AND USAGE
-
WARNINGS
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma(wheezing)
- shock
- 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
- takes 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.
- OTC - DO NOT USE
-
OTC - ASK DOCTOR
Ask a doctor before use if
- 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, asthma, or had a stroke
- you are taking a diuretic
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
-
OTC - STOP USE
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
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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 appear
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE AND ADMINISTRATION
- do not take 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 exceed 6 tablets in 24 hours, unless directed by a doctor
Children under
12 years- ask a doctor
- OTHER INFORMATION
-
INACTIVE INGREDIENTS
Brown Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Titanium Dioxide
Orange Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, FD&C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Titanium Dioxide
- QUESTIONS OR COMMENTS?
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN PAIN RELEIVER/ FEVER REDUCER
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53746-140 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code IP;140 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53746-140-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 12/16/2009 2 NDC:53746-140-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/16/2009 3 NDC:53746-140-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/16/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA071333 12/16/2009 IBUPROFEN PAIN RELEIVER/ FEVER REDUCER
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53746-143 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code IP;143 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53746-143-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 12/16/2009 2 NDC:53746-143-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/16/2009 3 NDC:53746-143-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/16/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA071333 12/16/2009 Labeler - Amneal Pharmaceuticals of New York LLC (123797875)