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

Ibuprofen

Western Family Foods, Inc.

  • 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
DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever/ Fever Reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • Headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
    • 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 an seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID) which may cause severe stomach bleeding. The chance are higher if you:

  • are age 60 or oder
  • have had stomach ulders or bleeding problems
  • take blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks everyday while using this prdouct
  • take more or for a longer time than directed.

Do not use

  • if you 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
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have asthma
  • you are taking a diuretic.

Ask a doctor or pharmacist before use if you are

  • taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • 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 bet better
    • Pain gets worse or last more than 10 days
    • Fever gets worse or last 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 druing the last 3 months of pegnancy unless defintely 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 (1-800-222-1222)

Directions

  • do not take more than directed
  • the smallest effective dose should be used
 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

Other information

  • store between 20o- 25o C (68o- 77o F)
  • read all warnings and directions before use. Keep carton
  • do not use if inner seal under bottle cap imprinted with "Sealed for your protection" is broken or missing
  • †This product is not manufactured or distributed by Pfizer consumer healthcare, owner of the registered trademark Advil®

Inactive Ingredients

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide

Questions or comments?

Call toll free: 1-503-639-6300 Monday- Friday 9AM-5PM PST

Principal Display Panel

Compare to the active ingredient in ADVIL®†

SEE NEW WARNINGS INFORMATION

Ibuprofen Tablets

Pain Reliever/ Fever Reducer (NSAID)**

Proudly distributed by Western family foods, Inc.

PO Box 4057, Portland, OR 97208 USA

www.westernfamily.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Product Label
Ibuprofen Tablets 200 mg

Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-118
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
ANHYDROUS LACTOSE
carnauba wax
SILICON DIOXIDE
HYPROMELLOSES
ferric oxide red
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
POVIDONES
SODIUM LAURYL SULFATE
sodium starch glycolate type a corn
titanium dioxide
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
BROWN 10 mm IP140 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 24 in 1 BOTTLE
3 NDC:55312-118-24 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072199 2011-02-01


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Be sure to consult your doctor before taking any medication!
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