Ibuprofen

Chain Drug Consortium LLC
Chain Drug Consortium LLC

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACTIVE INGREDIENT(S)
• PURPOSE
• USE(S)
• WARNINGS
• DO NOT USE
• ASK A DOCTOR BEFORE USE IF
• ASK A DOCTOR OR PHARMACIST BEFORE USE IF
• WHEN USING THIS PRODUCT
• STOP USE AND ASK DOCTOR IF
• PREGNANCY/BREASTFEEDING
• KEEP OUT OF REACH OF CHILDREN
• DIRECTIONS
• INACTIVE INGREDIENT(S)
• STORAGE
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT(S)

Ibuprofen 200 mg (NSAID)*

·        nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever / fever reducer

USE(S)

• temporarily relieves minor aches and pain due to :
• backache
• headache
• menstrual cramps
• minor pain of arthritis
• muscular aches
• the common cold
• toothache
• Temporarily reduces fever

WARNINGS

Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

Symptoms may include: 

• asthma (wheezing)
• blisters
• facial swelling
• hives
• rash
• shock
• skin reddening

If an allergic reaction occurs, stop use and seek medical help right away.

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

• are age 60 or older
• have bad stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• the 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
• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretics
• reached age 60 or older

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

you are

• taking any other drugs containg an NSAID (prescription or nonprescription)
• taking a blood thining (anticoagulant) or steriod drug
• under a doctor’s care for any serious condition
• taking aspirin for heart attacks or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

WHEN USING THIS PRODUCT

• take with food or milk if stomach upset occurs
• long term continuous use may increase the risk of heart attack or stroke

STOP USE AND ASK DOCTOR IF

• you feel faint, vomit blood, or have bloody or black stools.

        These are signs of stomach bleeding.

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• stomach pain or upset gets worse or lasts
• redness or swelling is present in painful area
• any new symptoms appear

PREGNANCY/BREASTFEEDING

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 a 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 PoisonControlCenter right away.

DIRECTIONS

• do not take more than directed
• the smallest effective dose should be used
• do not take longer than 10 days, unless directed by a doctor
  (see Warnings)

INACTIVE INGREDIENT(S)

Colloidal silicon dioxide, Croscarmellose Sodium, Magnesium stearate, Microcrystalline sodium, Pregelatinised starch, talc.

STORAGE

• store between 20-25 0c (68-77 0 F).
• do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing.

PRINCIPAL DISPLAY PANEL

Carton Label PDP

NDC# 68016-295-01

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

100 COATED TABLETS





Bottle Label PDP

NDC# 68016-295-01

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

100 COATED TABLETS




Carton Label PDP

NDC# 68016-295-50

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

50 COATED TABLETS





Bottle Label PDP

NDC# 68016-295-50

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

50 COATED TABLETS