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)**

____________________________________

* capsule-shaped tablets

** 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 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

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)

*capsule-shaped tablets

- 24 coated caplets*

- 50 coated caplets*

- 100 coated caplets*

- 165 coated caplets*

- 500 coated caplets*

- 1000 coated caplets*

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen Tablets USP 200 mg Carton
IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57910-403
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
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)  
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULE (Capsule Shaped) Size15mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57910-403-221 in 1 CARTON03/28/201109/12/2019
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:57910-403-231 in 1 CARTON03/28/201109/12/2019
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:57910-403-241 in 1 CARTON03/28/201109/12/2019
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:57910-403-251 in 1 CARTON03/28/201109/12/2019
4165 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:57910-403-29500 in 1 BOTTLE; Type 0: Not a Combination Product03/28/201109/12/2019
6NDC:57910-403-271000 in 1 BOTTLE; Type 0: Not a Combination Product03/28/201109/12/2019
7NDC:57910-403-281 in 1 BOX03/28/201109/12/2019
71000 in 1 BAG; Type 0: Not a Combination Product
8NDC:57910-403-301 in 1 BOX03/28/201109/12/2019
810000 in 1 BAG; Type 0: Not a Combination Product
9NDC:57910-403-311 in 1 BOX03/28/201109/12/2019
930000 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912903/28/201109/12/2019
Labeler - Shasun Pharmaceuticals Limited (650064850)
Registrant - Strides Shasun Limited (915786829)
Establishment
NameAddressID/FEIBusiness Operations
Strides Shasun Limited915786829MANUFACTURE(57910-403)

Revised: 9/2019
 
Shasun Pharmaceuticals Limited