RxNorm Names
IBUPROFEN tablet
[MARKSANS PHARMA LIMITED]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a991ef53-a633-476a-bb7c-1479aef2eb3b| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | Abbreviated New Drug Application |
Use(s)
- temporarily relieves minor aches and pain due to :
- backache
- headache
- menstrual cramps
- minor pain of arthritis
- muscular aches
- the common cold
- toothache
- temporarily reduces fever
Warnings
Allergy alerts: 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 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
you have
- 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
- ulcers
- 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
you are
- 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
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 PoisonControlCenter right away.
Directions
- 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
(see Wanings)
| adults and children 12 years and older |
|
| Children under 12 years |
|
Inactive ingredient(s)
Microcrystalline sodium, Crosscarmellose Sodium, Pregelatinised starch, talc, Colloidal silicon dioxide, Magnesium stearate.
Storage
- 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.
Manufactured for:
Marksans Pharma Inc.
3-Phillips Ln,
Lake Grove, NY 11755, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83, Verna Indl. Estate,
Verna, Goa-403 722, India.
| IBUPROFEN
ibuprofen tablet |
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| IBUPROFEN
ibuprofen tablet |
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| Labeler - MARKSANS PHARMA LIMITED (925822975) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| MARKSANS PHARMA LIMITED | 925822975 | MANUFACTURE(25000-115, 25000-120) | |
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