Ibuprofen description, usages, side effects, indications, overdosage, supplying and lots more!

Ibuprofen

Polygen Pharmaceuticals LLC
Polygen Pharmaceuticals LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT(S)

(each Caplet contains)

Ibuprofen 200 mg (NSAID)*

·        Non-steroidal 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 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 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 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 older
  • take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor.
Children under 12 years
  • ask a doctor

STORAGE

  • Store between 20-250C (68-770F).
  • do not use if seal under bottle cap is broken or missing.

INACTIVE INGREDIENTS

Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized starch, talc, Colloidal silicon dioxide, Magnesium stearate,polyvinyl Alcohol, Polyethylene glycol,Titanium dioxide.

PRINCIPAL DISPLAY PANEL

Carton Label
Thrulife
NDC : 52605-120-01
IBUPROFEN TABLETS, 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED CAPLETS
CAPSULE SHAPED TABLETS

PRINCIPAL DISPLAY PANEL




Bottle label PDP
Thrulife
NDC:52605-120-01
IBUPROFEN TABLETS USP, 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED CAPLETS
CAPSULE SHAPED TABLETS

PRINCIPAL DISPLAY PANEL





Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52605-120
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
talc
MAGNESIUM STEARATE
STARCH, CORN
COLLOIDAL SILICON DIOXIDE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 15 mm 120 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:52605-120-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091237 2013-07-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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