IBUPROFEN- ibuprofen tablet 
The Kroger Co.

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DRUG FACTS

Active Ingredient (in each caplet)

Ibuprofen USP, 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Purpose

Pain Releiver/ Fever Reducer

Uses

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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:

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)

Directions

  • 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

Other information

  • 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 Dioxide

Questions or comments?

Call 1-800-632-6900

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 45202

Product Label

The Kroger Co. Ibuprofen Caplets

Ibuprofen 200 mg tablets

IBUPROFEN 
ibuprofen tablet
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)

Revised: 9/2012
Document Id: 4a340196-5385-43cc-98f5-01567d699359
Set id: f7afd7cb-870b-4ee9-aeaf-dcba9b40aa20
Version: 1
Effective Time: 20120927
 
The Kroger Co.