FAST PAIN RELIEF - ibuprofen tablet, coated 
We Care Distributor Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient(in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Purpose

Pain reliever/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 and seek medical help right away.


Stomach bleeding warning:

This product contains an NSAID, which may cause severe 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 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

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • 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
  • 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.


Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, magnesium stearate,microcrystalline cellulose, talc, titanium dioxide


Questions or Comments

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com


Principal Display Panel

NDC 70005-009-25

SEE NEW WARNINGS AND DIRECTIONS

We Care

For Good Health

COMPARE TO ACTIVE INGREDIENT IN Advil®* CAPLETS

TO OPEN PUSH IN TAB AND PULL OUT

Ibuprofen 200 mg

Pain Reliever/Fever Reducer (NSAID)



Ibuprofen

*This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®* tablets.

25 Pouches of 2 Coated Tablets



Untitled.jpg

FAST PAIN RELIEF 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-009-024 in 1 POUCH; Type 0: Not a Combination Product
2NDC:70005-009-2525 in 1 CARTON
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:70005-009-5050 in 1 CARTON
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/02/2015
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(70005-009)

Revised: 12/2015
Document Id: 0a2f27ca-98e4-44f5-b812-b3803f61f762
Set id: 16b751a9-2f33-4303-b75f-ca0c012a212d
Version: 1
Effective Time: 20151202
 
We Care Distributor Inc.