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)*

* nonstreoidal 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 allergy 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 a 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 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 longer than directed.  

Do not use

• if you have ever had an allergic reaction to ibuprofen 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 a high blood pressure, heart disease,cirrhosis,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

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

Other information

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

Inactive ingredients

Silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide. 

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 Industrial Estate
Verna, Goa-403722, India  

Storage

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

500 counts
Bottle Label

Ibuprofen Tablets USP, 200mg

1000 counts
Bottle Label

Ibuprofen Tablets USP, 200mg (Caplets)

300 counts
Bottle Label

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-114
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	114
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-114-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2011
2	NDC: 25000-114-14	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2011
3	NDC: 25000-114-20	4 in 1 BOX	07/25/2011
3		6500 in 1 BAG; Type 0: Not a Combination Product
4	NDC: 25000-114-30	6 in 1 BOX	07/25/2011
4		6500 in 1 BAG; Type 0: Not a Combination Product
5	NDC: 25000-114-98	1 in 1 BOX	07/25/2011
5		34065 in 1 BAG; Type 0: Not a Combination Product
6	NDC: 25000-114-93	1 in 1 BOX	07/25/2011
6		37470 in 1 BAG; Type 0: Not a Combination Product
7	NDC: 25000-114-70	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2011
8	NDC: 25000-114-71	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091239	07/25/2011

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-117
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	BROWN	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	117
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-117-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2011
2	NDC: 25000-117-14	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2011
3	NDC: 25000-117-20	4 in 1 BOX	07/25/2011
3		6500 in 1 BAG; Type 0: Not a Combination Product
4	NDC: 25000-117-30	6 in 1 BOX	07/25/2011
4		6500 in 1 BAG; Type 0: Not a Combination Product
5	NDC: 25000-117-98	1 in 1 BOX	07/25/2011
5		34065 in 1 BAG; Type 0: Not a Combination Product
6	NDC: 25000-117-93	1 in 1 BOX	07/25/2011
6		37470 in 1 BAG; Type 0: Not a Combination Product
7	NDC: 25000-117-69	300 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091239	07/25/2011

Labeler - MARKSANS PHARMA LIMITED (925822975)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	LABEL(25000-117) , MANUFACTURE(25000-114, 25000-117)