IBUPROFEN TABLETS USP 200 mg
Drug Labeling and Warnings
Drug Details [pdf]
IBUPROFEN- ibuprofen tablet, coated
Shasun Pharmaceuticals Limited
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IBUPROFEN TABLETS USP 200 mg
OTC - ACTIVE INGREDIENT SECTION
Ibuprofen, USP 200 mg (NSAID)**
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* capsule-shaped tablets
** 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 caplet every 4 to 6 hours while symptoms persist ■ if pain or fever does not respond to 1 caplet, 2 caplets may be used ■ do not exceed 6 caplets 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, FD&C Yellow #6 Al.Lake, sodium starch glycolate, titanium dioxide, triacetin and talc
SPL UNCLASSIFIED
Shasun Pharmaceuticals Limited,
Unit-II, R.S. No.: 32, 33, 34,
Shasun Road, Periyakalapet,
Puducherry - 605014, INDIA
See New Warnings Information
Ibuprofen Tablets USP 200 mg
Pain Reliever / Fever Reducer (NSAID)
*capsule-shaped tablets
- 24 coated caplets*
- 50 coated caplets*
- 100 coated caplets*
- 165 coated caplets*
- 500 coated caplets*
- 1000 coated caplets*
| IBUPROFEN
ibuprofen tablet, coated |
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| Labeler - Shasun Pharmaceuticals Limited (650064850) |
| Registrant - Strides Shasun Limited (915786829) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Strides Shasun Limited | 915786829 | MANUFACTURE(57910-402) | |