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Ibuprofen Capsules

Pronunciation

Dosage Form: capsule, liquid filled

Active ingredient (in each capsule)

Ibuprofen 200 mg (NSAID)*
 *nonsteroidal anti-inflammatory drug

Purposes


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

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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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.  The chance is 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 an NSAID [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
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretic
  • reached age 60 or older                                                                                                                                               

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug                                                                                                                                                        

When using this product

  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke

Stop use and ask doctor if

  • you feel faint, vomit blood, or have bloody or black stools.  These are signs of stomach bleeding.                                             
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • 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 PoisonControlCenter right away.

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 over:
    • take 1 capsule every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 capsule, 2 capsules may be used
    • do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years:  ask a doctor

Other information

  • each capsule contains: potassium 15 mg
  • read all warnings and directions before use.  Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • do not use if Tamper-Evident seal under bottle cap imprinted with “Sealed for Your Protection” is broken or missing                                                                                   

Inactive ingredients

FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

Manufactured by: 
Banner Pharmacaps Inc.
4125 Premier Drive
High Point, NC27265

IMPORTANT

This bulk shipment is intended for further processing only. It is not to be used in its present condition, and it should be re-packaged immediately, and labeled strictly in conformance with the FD&C Act and regulations. Store below 60% relative humidity at 59°-86°F (15°-30°C)-do not refrigerate.

CAUTION:  FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING ONLY.

 

BANNER PHARMACAPS Inc. BULK LABEL

Principal Display Panel Shipping Label

NDC 10888-7133-1

Ibuprofen 200 mg 

(Liquid Filled Capsules)
6,000 Softgels
IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10888-7133
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
FD&C BLUE NO. 1  
GELATIN  
POLYETHYLENE GLYCOL  
POTASSIUM HYDROXIDE  
WATER  
SORBITAN  
SORBITOL  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:10888-7133-1 1 BAG (1 BAG) in 1 BOX
1 6000 CAPSULE, LIQUID FILLED (6000 CAPSULE) in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078682 03/15/2009
Labeler - Banner Pharmacaps Inc (002193829)
Establishment
Name Address ID/FEI Operations
Banner Pharmacaps Inc 002193829 MANUFACTURE
Revised: 05/2010
 
Banner Pharmacaps Inc



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