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Ibuprofen by Weeks & Leo Co., Inc.

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Weeks & Leo Co., Inc.
NDC Code: 11383-151

ACTIVE INGREDIENT(S)

Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug

PURPOSE

Pain reliever / fever reducer

USE(S)
  • temporarily relieves minor aches and pain due to :
  • backache
  • headache
  • menstrual cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever

WARNINGS

Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

Symptoms may include: 

  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • skin reddening

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 bad stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • the 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 diuretics
  • reached age 60 or older

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

you are

  • taking any other drugs containg an NSAID (prescription or nonprescription)
  • taking a blood thining (anticoagulant) or steriod drug
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attacks 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 painful area
  • any new symptoms appear

PREGNANCY/BREASTFEEDING

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 a 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 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

STORAGE
  • Store between 20-250C(68-77 0F).
  • Do not use if seal under bottle cap imprinted with "SEALED  for YOUR PROTECTION" is broken or missing.

INACTIVE INGREDIENTS

colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, titanium dioxide.

PRINCIPAL DISPLAY PANEL

Carton Label PDP

Ibuprofen 200mg CAPLET

PAIN RELIEVER/ FEVER REDUCER (NSAID)

















IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-151
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
FERRIC OXIDE RED 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
POLYVINYL ALCOHOL 
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code117
Contains    
Packaging
#Item CodePackage Description
1NDC:11383-151-501 BOTTLE in 1 CARTON
150 TABLET, COATED in 1 BOTTLE
2NDC:11383-151-111 BOTTLE in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE
3NDC:11383-151-211 BOTTLE in 1 CARTON
3200 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123905/17/2013
Labeler - Weeks & Leo Co., Inc. (005290028)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIOperations
Marksans Pharma Limited925822975MANUFACTURE(11383-151)

Revised: 05/2013
 
Weeks & Leo Co., 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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