Label: IBUPROFEN - ibuprofen tablet
view more25000-120-14, 25000-120-30
- Packager: MARKSANS PHARMA LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient(s)
Ibuprofen 200 mg (NSAID)*
· nonstreoidal anti-inflammatory drugClose
Pain reliever / fever reducer Close
- temporarily relieves minor aches and pain due to :
- menstrual cramps
- minor pain of arthritis
- muscular aches
- the common cold
- temporarily reduces fever
Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include:
- asthma (wheezing)
- facial swelling
- skin reddening
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 drug containing prescription NSAID (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
- 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
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- bleeding problems
- high blood pressure
- heart or kidney disease
- taken a diuretics
- reached age 60 or older
- Ask a doctor or pharmacist before use if
- taking any other drugs containg an NSAID (prescription or nonprescription)
- taking a blood thining (anticoagulant) or steriod drug
- under a doctor’s care for any serious condition
- taking aspirin for heart attacks or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
- When using this product
- take with food or milk if stomach upset occurs
- long term continuous use may increase the risk of heart attack or stroke
- Stop use and ask doctor if
- you feel faint, vomit blood, or have bloody or black stools.
These are signs of stomach bleeding.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- stomach pain or upset gets worse or lasts
- redness or swelling is present in painful area
- any new symptoms appear
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.Close
- Keep out of reach of children
In case of overdose, get medical help or contact a PoisonControlCenter right away. Close
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a docter
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)
Microcrystalline sodium, Crosscarmellose Sodium, Pregelatinised starch, talc, Colloidal silicon dioxide, Magnesium stearate. Close
- 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.
Marksans Pharma Inc.
Lake Grove, NY 11755, USA
Marksans Pharma Ltd.
Plot No. L-82, L-83, Verna Indl. Estate,
Verna, Goa-403 722, India. Close
- Principal Display Panel
1000's count coated Tablets:
Ibuprofen Tablets, USP 200mg
1000's count coated Tablets:
Ibuprofen Tablets, USP 200mg
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:25000-115 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM STARCH, CORN TALC COLLOIDAL SILICON DIOXIDE MAGNESIUM STEARATE Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code 115 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-115-03 30 in 1 BOTTLE 2 NDC:25000-115-14 1000 in 1 BOTTLE 3 NDC:25000-115-30 6 in 1 BOX 3 6500 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091237 07/04/2012 IBUPROFEN
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:25000-120 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM STARCH, CORN TALC COLLOIDAL SILICON DIOXIDE MAGNESIUM STEARATE Product Characteristics Color WHITE Score no score Shape CAPSULE Size 15mm Flavor Imprint Code 120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-120-03 30 in 1 BOTTLE 2 NDC:25000-120-14 1000 in 1 BOTTLE 3 NDC:25000-120-30 6 in 1 BOX 3 6500 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091237 07/04/2012 Labeler - MARKSANS PHARMA LIMITED (925822975) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 MANUFACTURE(25000-115, 25000-120)