Ibuprofen: Package Insert and Label Information

IBUPROFEN — ibuprofen tablet, coated
Weeks & Leo Co., Inc.

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 20-250 C (68-77 0 F).
  • 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)
ibubr cap

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Ibu-cap-br
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Ibu-cap-br
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ibu-cap-br
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IBUPROFEN
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11383-151
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
FERRIC OXIDE RED
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
TALC
TITANIUM DIOXIDE
STARCH, CORN
POLYVINYL ALCOHOL
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 117
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11383-151-50 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (11383-151-50)
2 NDC:11383-151-11 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (11383-151-11)
3 NDC:11383-151-21 1 BOTTLE in 1 CARTON contains a BOTTLE
3 200 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (11383-151-21)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091239 05/17/2013
Labeler — Weeks & Leo Co., Inc. (005290028)
Registrant — Weeks & Leo Co., Inc. (005290028)
Establishment
Name Address ID/FEI Operations
Marksans Pharma Limited 925822975 MANUFACTURE (11383-151)

Revised: 05/2013 Weeks & Leo Co., Inc.

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