Ibuprofen by Shasun Pharmaceuticals Limited
Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Shasun Pharmaceuticals Limited
NDC Code: 57910-403
Ibuprofen, USP 200 mg (NSAID)**
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* capsule-shaped tablets
** nonsteroidal anti-inflammatory drug
Pain reliever / fever reducer
■ 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
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.
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
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- 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
- 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
- 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
■ 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
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 problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- 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 |
■ 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.
colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide, triacetin and talc
Call 1-732-465-0700: weekdays 8.00 AM to 8.00 PM
Manufactured by:
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 - Shasun Pharmaceuticals Limited (915786829) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Shasun Pharmaceuticals Limited | 915786829 | Manufacture | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.
