Label: CAREALL IBUPROFEN- ibuprofen tablet
- NDC Code(s): 51824-064-01
- Packager: New World Imports
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 11, 2021
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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, 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 60 years or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoaglant) or steroid drug, take other drugs containing a NSAID [aspirin, ibuprofen, naproxen, or others], have 3 or more alcoholic drinks every day while using this product, or take more / for a longer time than directed.
Heart attack and stroke warning: NSAID's, 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 or right before / 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. You have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke. You are taking a diuretic.
Ask a doctor or pharmacist before use if you are: taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin. Under a doctor's care for any serious condition, 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, weakness in one part or side of body, slurred speech, or 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.
Pregnant or breast-feeding: ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
DOSAGE & ADMINISTRATION
Do not take more than directed. The smallest effective dose should be used.
Adult and children 12 years and older: Take 1 tablets every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablets, 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
colloidal silicon dioxide, pregelatinized starch, titanium dioxide, corn starch, croscarmellose sodium, FDandC yellow 6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, sodium starch glycolate, stearic acid, talc, triacetin
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-064 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) HYPROMELLOSES (UNII: 3NXW29V3WO) Ferric Oxide Red (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) Cellulose, Microcrystalline (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TALC (UNII: 7SEV7J4R1U) TRIACETIN (UNII: XHX3C3X673) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown (Rusty brown color) Score no score Shape ROUND (Round) Size 10mm Flavor Imprint Code IBU200;114;G2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-064-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/11/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/11/2017 Labeler - New World Imports (075372276) Registrant - New World Imports (075372276)