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Ibuprofen by Shasun Pharmaceuticals Limited

Medically reviewed on June 6, 2018

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Shasun Pharmaceuticals Limited
NDC Code: 57910-400

IBUPROFEN TABLETS USP 200 mg

Active ingredient (in each orange 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
  • 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 tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57910-400
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeIBU200
Contains    
Packaging
#Item CodePackage Description
1NDC:57910-400-011 BOTTLE (BOTTLE) in 1 CARTON
124 TABLET, COATED (TABLET) in 1 BOTTLE
2NDC:57910-400-021 BOTTLE (BOTTLE) in 1 CARTON
250 TABLET, COATED (TABLET) in 1 BOTTLE
3NDC:57910-400-031 BOTTLE (BOTTLE) in 1 CARTON
3100 TABLET, COATED (TABLET) in 1 BOTTLE
4NDC:57910-400-041 BOTTLE (BOTTLE) in 1 CARTON
4165 TABLET, COATED (TABLET) in 1 BOTTLE
5NDC:57910-400-08500 TABLET, COATED (TABLET) in 1 BOTTLE
6NDC:57910-400-061000 TABLET, COATED (TABLET) in 1 BOTTLE
7NDC:57910-400-071 BAG (BAG) in 1 BOX
71000 TABLET, COATED (TABLET) in 1 BAG
8NDC:57910-400-091 BAG (BAG) in 1 BOX
810000 TABLET, COATED (TABLET) in 1 BAG
9NDC:57910-400-101 BAG (BAG) in 1 BOX
930000 TABLET, COATED (TABLET) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135504/04/2011
Labeler - Shasun Pharmaceuticals Limited (650064850)
Registrant - Shasun Pharmaceuticals Limited (915786829)
Establishment
NameAddressID/FEIOperations
Shasun Pharmaceuticals Limited915786829Manufacture

 
Shasun Pharmaceuticals Limited

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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