Your browser does not support JavaScript! IBUPROFEN TABLET [THE KROGER CO.]
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RxNorm Names

IBUPROFEN tablet
[The Kroger Co.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active Ingredient (in each caplet)

Ibuprofen USP, 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Purpose

Pain Releiver/ Fever Reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • Headache
  • muscular aches
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever

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 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)

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-167
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POVIDONES 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code IP142
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-167-05500 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07219902/02/2011
Labeler - The Kroger Co. (006999528)

Revised: 9/2012
 
The Kroger Co.

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