Ibuprofen (NSAID) Pain Reliever/Fever Reducer

A&Z Pharmaceutical, Inc.
A&Z Pharmaceutical, Inc.

Ibuprofen 200mg

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACTIVE INGREDIENTS
• PURPOSES
• USES
• WARNINGS
  • Do Not Use
  • Ask a doctor before use if
  • Ask a Doctor/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
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

(in each tablet)

Ibuprofen USP, 200mg (NSAID)**

**nonsteroidal anti-inflammatory drug

PURPOSES

Pain reliever/fever reducer

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
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take 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/Pharmacist before use if you are

• taking aspirin to prevent 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 last 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 right away (1-800-222-1222).

DIRECTIONS

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

Adults and children under 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.

OTHER INFORMATION

• store between 20-25°C (68-77°F).
• Read all warnings and directions before use
• Do not use if seal under bottle cap is broken or missing.

INACTIVE INGREDIENTS

Brown tablets: colloidal silicon dioxide, corn starch, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, tricaetin.

Orange caplets: colloidal silicon dioxide, corn starch, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin.

QUESTIONS

Call 1-888-952-0050 Monday through Friday 9AM-5PM EST.

HealthA2Z® Ibuprofen is not manufactured or distributed by Wyeth Consumer Healthcare, distributor of Advil®

Manufactured for:

A&Z Pharmaceutical, Inc.,

Hauppauge, NY 11788

Product made in India

PRINCIPAL DISPLAY PANEL