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Ibuprofen

Shasun Pharmaceuticals Limited
Shasun Pharmaceuticals Limited

IBUPROFEN TABLETS USP 200 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each orange tablet)

Ibuprofen, USP 200 mg (NSAID)*

____________________________________

* nonsteroidal 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
  • rash
  • blisters
  • shock
  • skin reddening
  • asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains a non-steroidal anti-inflammatory drug (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

  • 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 for 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 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 (1-800-222-1222) right away.

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 20-25°C (68-77°F)

tamper evident: do not use if imprinted safety seal under cap is broken or missing;

                                  do not use if seal is open or missing in bulk pack.

Inactive Ingredients

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, FD&C Yellow #6 Al.Lake, sodium starch glycolate, titanium dioxide, triacetin and talc

Questions or comments?

Call 1-732-465-0700: weekdays 8.00 AM to 8.00 PM

Manufactured by:

Shasun Pharmaceuticals Limited,

Unit-II, R.S. No.: 32, 33, 34,

Shasun Road, Periyakalapet,

Puducherry - 605014, INDIA

See New Warnings Information

Ibuprofen Tablets USP 200 mg

Pain Reliever / Fever Reducer (NSAID)

- 24 coated tablets

- 50 coated tablets

- 100 coated tablets

- 165 coated tablets

- 500 coated tablets

- 1000 coated tablets

Principal Display Panel

Ibuprofen

Ibuprofen

Ibuprofen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57910-400
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
COLLOIDAL SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
cellulose, microcrystalline
STARCH, PREGELATINIZED CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide
triacetin
talc
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
ORANGE 10 mm IBU200 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 50 in 1 BOTTLE
3 100 in 1 BOTTLE
4 165 in 1 BOTTLE
5 NDC:57910-400-08 500 in 1 BOTTLE
6 NDC:57910-400-06 1000 in 1 BOTTLE
7 1000 in 1 BAG
8 10000 in 1 BAG
9 30000 in 1 BAG
10 NDC:57910-400-10 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091355 2011-04-04


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Be sure to consult your doctor before taking any medication!
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