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Fast Pain Relief by We Care Distributor Inc.

Medically reviewed on December 4, 2017

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: We Care Distributor Inc.
NDC Code: 70005-009

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

  • 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 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.


  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information
  • each tablet contains: sodium 22 mg
  • read all warnings and directions before use
  • Keep carton or card
  • store at 20 - 25°C (68 - 77°F)
  • avoid excessive heat above 40°C (104°F)

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)



  • Headache
  • Toothache
  • Minor Pain of Arthritis
  • Fever
  • Muscularache
  • Menstrual Cramps

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




FAST PAIN RELIEF 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-009
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeG2
Contains    
Packaging
#Item CodePackage Description
1NDC:70005-009-024 TABLET, COATED in 1 POUCH
2NDC:70005-009-2525 POUCH in 1 CARTON
22 TABLET, COATED in 1 POUCH
3NDC:70005-009-5050 POUCH in 1 CARTON
32 TABLET, COATED in 1 POUCH
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/FEIOperations
Granules India Limited918609236manufacture(70005-009)

 
We Care Distributor Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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