Ibuprofen by MARKSANS PHARMA LIMITED IBUPROFEN tablet

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Otc medication manufactured, distributed, or labeled by MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)  

Ibuprofen 200 mg (NSAID)*

  * nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever/fever reducer

Use(s)

• temporarily relieves minor aches and pains due to:
  • backache
  • headache
  • menstrual cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
• temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include: 

• asthma (wheezing)
• blisters
• facial swelling
• hives
• rash
• shock
• skin reddening

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 bad 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
• the more or for a longer time than directed
•  Heart attack and stroke warning: NSAID's except aspirin, increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.  

Do not use

• if you have ever had an allergic reaction to ibuprofen or or 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, asthma, or had a stroke. 
• 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

Stop use and ask 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
• You have symptoms of heart problem  or stroke:
  • Chest pain
  • Trouble breathing
  • Weakness in one part or side of body
  • Slurred speech
  • leg swelling
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in painful area
• any new symptoms appear

Other required warnings

Pregnancy/Breastfeeding

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 a 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. (1-800-222-1222)

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

Inactive ingredient(s)

Silicon dioxide, croscarmellose sodium, FD & C yellow # 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.

Storage

• store between 20-25 0C (68-77 0F).
• do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION” is broken or missing.

Questions or comments?

Call 1-877-290-4008


Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA

Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83,
Verna Indl. Estate,
Verna, Goa-403 722, India.

Principal Display Panel

Ibuprofen Tablets, USP 200mg

30 counts
Bottle Label

Ibuprofen Tablets, USP 200mg

30 counts
Carton Label

   

Ibuprofen Tablets, USP 200mg (Caplets)

30 counts
Bottle Label

Ibuprofen Tablets, USP 200mg (Caplets)

30 counts
Carton Label

Ibuprofen Tablets, USP 200mg

300 counts
Bottle Label

Ibuprofen Tablets, USP 200mg

1000 counts
Bottle Label

Ibuprofen Tablets, USP 200mg (Caplets)

500 counts
Bottle Label

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-135
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE (Capsule Shaped)	Size	10mm
Flavor		Imprint Code	120
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-135-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2015
2	NDC: 25000-135-14	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2015
3	NDC: 25000-135-30	6 in 1 BOX	11/06/2015
3		6500 in 1 BAG; Type 0: Not a Combination Product
4	NDC: 25000-135-98	1 in 1 BOX	11/06/2015
4		34065 in 1 BAG; Type 0: Not a Combination Product
5	NDC: 25000-135-93	1 in 1 BOX	11/06/2015
5		37470 in 1 BAG; Type 0: Not a Combination Product
6	NDC: 25000-135-70	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091237	11/06/2015

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-136
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND (Round Shaped)	Size	15mm
Flavor		Imprint Code	115
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-136-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2015
2	NDC: 25000-136-14	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2015
3	NDC: 25000-136-30	6 in 1 BOX	11/06/2015
3		6500 in 1 BAG; Type 0: Not a Combination Product
4	NDC: 25000-136-98	1 in 1 BOX	11/06/2015
4		34065 in 1 BAG; Type 0: Not a Combination Product
5	NDC: 25000-136-93	1 in 1 BOX	11/06/2015
5		37470 in 1 BAG; Type 0: Not a Combination Product
6	NDC: 25000-136-69	300 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2015
7	NDC: 25000-136-71	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091237	11/06/2015

Labeler - MARKSANS PHARMA LIMITED (925822975)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	MANUFACTURE(25000-135, 25000-136)