IBUPROFEN- ibuprofen tablet, coated 
Shasun Pharmaceuticals Limited

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IBUPROFEN TABLETS USP 200 mg

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen, USP 200 mg (NSAID)*

____________________________________

* nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain reliever / fever reducer

INDICATIONS AND USAGE

■    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.

OTC - 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.

DOSAGE AND ADMINISTRATION

  • 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

STORAGE AND HANDLING

■ 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 INGREDIENT

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide, triacetin and talc

OTC - QUESTIONS

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

SPL UNCLASSIFIED

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Iuprofen Tablet USP 200 mg Carton Label
IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57910-401
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57910-401-091 in 1 CARTON04/28/201109/10/2019
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:57910-401-101 in 1 CARTON04/28/201109/10/2019
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:57910-401-111 in 1 CARTON04/28/201109/10/2019
3165 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:57910-401-15500 in 1 BOTTLE; Type 0: Not a Combination Product04/28/201109/10/2019
5NDC:57910-401-131000 in 1 BOTTLE; Type 0: Not a Combination Product04/28/201109/10/2019
6NDC:57910-401-141 in 1 BOX04/28/201109/10/2019
61000 in 1 BAG; Type 0: Not a Combination Product
7NDC:57910-401-161 in 1 BOX04/28/201109/10/2019
710000 in 1 BAG; Type 0: Not a Combination Product
8NDC:57910-401-171 in 1 BOX04/28/201109/10/2019
830000 in 1 BAG; Type 0: Not a Combination Product
9NDC:57910-401-081 in 1 CARTON04/28/201109/10/2019
924 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912904/28/201109/10/2019
Labeler - Shasun Pharmaceuticals Limited (650064850)
Registrant - Strides Shasun Limited (915786829)
Establishment
NameAddressID/FEIBusiness Operations
Strides Shasun Limited915786829MANUFACTURE(57910-401)

Revised: 9/2019
 
Shasun Pharmaceuticals Limited