Label: IBUPROFEN- ibuprofen tablet
- NDC Code(s): 30142-167-05
- Packager: The Kroger Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredient (in each caplet)
Ibuprofen USP, 200 mg (NSAID)**
**nonsteroidal anti-inflammatory drugClose
- temporarily relieves minor aches and pains due to:
- muscular aches
- minor pain of arthritis
- the common cold
- menstrual cramps
- temporarily reduces fever
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- facial swelling
- asthma (wheezing)
- skin reddening
If an allergic reaction occurs, stop use an seek medical help right away.
Stomach bleeding warning: This product contains an NSAID which may cause sever stomach bleeding. The chance is higher if you:
- are age 60 or oder
- have had stomach ulders or bleeding problems
- take blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks everyday while using this prdouct
- take more or for a longer time than directed.
Do not use
- if you ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- you have problems or serious side effects from taking pain relievers or fever reducers
- the stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have asthma
- 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
- 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
- You experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stoolos
- have stomach pain that does not bet better
- Pain gets worse or last more than 10 days
- Fever gets worse or last more than 3 days
- Redness or swelling is presentin the painful area
- Any new symptoms appear
If pregnant or breast-feeding
ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
- Adults and children 12 years and older:
- take 1 caplet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 caplet, 2 caplets may be used.
- do not exceed 6 caplets in 24 hours, unless directed by a doctor
- Children under 12 years: ask a doctor
- do not use in children under 4 years of age
- store between 20o- 25o C (68o- 77o F)
- read all warnings and directions before use.
- do not use if inner seal under bottle cap imprinted with "Sealed for your protection" is broken or missing
- Inactive Ingredients
Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium DioxideClose
- Questions or comments?
- Principal Display Panel
Compare to the active ingredient of ADVIL® †See back panel
SEE NEW WARNINGS INFORMATION
Ibuprofen Tablets USP, 200 mg
Pain Reliever/ Fever Reducer (NSAID)**
**CAPSULE SHAPED TABLETS
†Advil® is a registered trademark of Wyeth corporation, Madison, NJ 07940. Wyeth corporation is not affiliated with the Kroger Co. or this product
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202Close
- Product Label
Ibuprofen 200 mg tablets
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-167 Route of Administration ORAL DEA Schedule 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 GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BROWN Score no score Shape CAPSULE Size 14mm Flavor Imprint Code IP142 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-167-05 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA072199 02/02/2011 Labeler - The Kroger Co. (006999528)