- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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 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 presrciption 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: • 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 • high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
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 • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if: • 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
• 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:
• chst pain • trouble breathing •weakness in one part or side of body • slurred speech • leg swelling
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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 of age: ask a doctor
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INACTIVE INGREDIENT
crosscarmellose sodium*, FD& C Blue #2*, FD& C red #40*, FD& C Yellow #6*, hypromellose*, iron oxide red*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium chain triglycerides*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, povidone (K-30)*, silicon dioxide, sodium starch glycolate*, starch, stearic acid*, talc*, titanium dioxide, triacetin* *contains one or more of these ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen 200mg tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29485-7625 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POVIDONE K30 (UNII: U725QWY32X) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) TRIACETIN (UNII: XHX3C3X673) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code G2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29485-7625-6 3 in 1 PACKAGE 03/13/2019 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 03/13/2019 Labeler - Mechanical Servants LLC (005530951)