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

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Ibuprofen

AAA Pharmaceutical, Inc.

Ibuprofen Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each caplet)

Ibuprofen, USP 200 mg (NSAIDnonsteroidal anti-inflammatory drug)

Purpose

Pain reliever/fever reducer

Ibuprofen 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 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

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • 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.

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 over
  • 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

Ibuprofen Other information

  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • read all warnings and directions before use
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone K30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

RESTORE u

NDC 57344-112-03

†COMPARE TO THE
ACTIVE INGREDIENT
IN MOTRIN IB®

Ibuprofen
Tablets, USP 200 mg

Pain Reliever, Fever Reducer
(NSAID)

100 COATED CAPLETS** (**capsule-shaped tablets)

Ibuprofen

Ibuprofen

Ibuprofen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-112(NDC:57910-402)
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
SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSES
FD&C YELLOW NO. 6
ALUMINUM OXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
POVIDONE K30
sodium starch glycolate type a corn
STEARIC ACID
talc
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
ORANGE 15 mm IBU;200 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE, PLASTIC
2 50 in 1 BOTTLE, PLASTIC
3 100 in 1 BOTTLE, PLASTIC
4 250 in 1 BOTTLE, PLASTIC
5 100 in 1 BOTTLE, PLASTIC
6 NDC:57344-112-08 225 in 1 BOTTLE, PLASTIC
7 NDC:57344-112-05 500 in 1 BOTTLE, PLASTIC
8 NDC:57344-112-06 1000 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091355 2012-12-04


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Be sure to consult your doctor before taking any medication!
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