Ibuprofen

Shasun Pharmaceuticals Limited
Shasun Pharmaceuticals Limited

IBUPROFEN TABLETS USP 200 mg

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each orange caplet*)
• Purpose
• Ibuprofen Uses
• Warnings
  • Allergy alert
  • Stomach bleeding warning
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Other Information
• Inactive Ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each orange caplet*)

Ibuprofen, USP 200 mg (NSAID)**

____________________________________

* capsule-shaped tablets

** nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Ibuprofen Uses

■    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

If pregnant or breast-feeding,

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.

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.

Directions

• do not take more than directed
• the smallest effective dose should be used

Other Information

■ 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 Ingredients

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

Questions or comments?

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*

Principal Display Panel