Label: IBUPROFEN tablet, coated
- NDC Code(s): 68210-4200-3
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 13, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient (in each tablet)
- Purpose
- Uses
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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 a nonsteroidal anti-inflammatory drug (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 directedHeart attack and stroke warning: NSAID's except aspirin increases 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, asthma, or had a stroke • you are taking a diureticAsk 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 drugStop 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 -
Directions
• 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
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Inactive ingredients
Colloidal silicon dioxide, corn starch, croscarmellose sodium*, hypromellose, iron oxide red, magnesium stearate*, microcrystalline cellulose*, polyethylene glycol, polyvinyl alcohol, povidone K-30*, pregelatinized starch, sodium starch glycolate*, stearic acid*, talc, titanium dioxide, triacetin.
*contains one or more of these ingredients - Questions or comments?
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4200 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE B CORN (UNII: 2LI18Q1ZCG) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) HYPROMELLOSES (UNII: 3NXW29V3WO) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TRIACETIN (UNII: XHX3C3X673) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color orange Score no score Shape CAPSULE Size 15mm Flavor Imprint Code IBU;200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4200-3 1 in 1 CARTON 06/15/2022 1 40 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 ANDA091355 06/15/2022 Labeler - Spirit Pharmaceuticals LLC (179621011)
