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Package Insert and Label Information: Up and Up Ibuprofen

By Target Corporation | Last revised: 30 December 2012

UP AND UP IBUPROFEN- ibuprofen tablet
Target Corporation

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/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 and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chances are 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 prescription 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

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

  • 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 stools
  • have stomach pain that does not get better
  • 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

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely 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

adults and children 12 years and

  • 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

Other information

  • read all warnings and directions before use
  • store at 20-25°C (68-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • see end panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

Questions?

Call 1-800-910-6874

Principal Display Panel

ibuprofen tablets, 200 mg

pain reliever/fever reducer (NSAID)

Compare to active ingredient in Advil®

see new warnings information

†CAPSULE-SHAPED TABLETS

ACTUAL SIZE

# CAPLETS {Replace “#” with number of caplets in package}

Ibuprofen Tablets, 200 mg Carton Image 1
(click image for full-size original)

Ibuprofen Tablets, 200 mg Carton Image 1

Ibuprofen Tablets, 200 mg Carton Image 2
(click image for full-size original)

Ibuprofen Tablets, 200 mg Carton Image 2

UP AND UP IBUPROFEN
ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-647
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSES
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code I2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11673-647-62 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 24 TABLET (TABLET) in 1 BOTTLE This package is contained within the CARTON (11673-647-62)
2 NDC:11673-647-85 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
2 250 TABLET (TABLET) in 1 BOTTLE This package is contained within the CARTON (11673-647-85)
3 NDC:11673-647-90 500 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072096 05/28/2009
Labeler — Target Corporation (006961700)

Revised: 12/2012 Target Corporation