IBUPROFEN TABLETS USP 200 mg
IBUPROFEN by
Drug Labeling and Warnings
IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by One2Zee Limited Liability Company, Strides Pharma Science Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
IBUPROFEN- ibuprofen tablet
One2Zee Limited Liability Company
----------
IBUPROFEN TABLETS USP 200 mg
OTC - ACTIVE INGREDIENT SECTION
Ibuprofen, USP 200 mg (NSAID)*
____________________________________
* nonsteroidal anti-inflammatory drug
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
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 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 |
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
| IBUPROFEN
ibuprofen tablet |
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
| Labeler - One2Zee Limited Liability Company (078656111) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Strides Pharma Science Limited | 871402375 | ANALYSIS(55629-095) , MANUFACTURE(55629-095) , PACK(55629-095) | |