Childrens Ibuprofen

Preferred Pharmaceuticals, Inc

Children’s Ibuprofen Oral Suspension, USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACTIVE INGREDIENT
• PURPOSE
• USES
• WARNINGS
• DO NOT USE
• ASK DOCTOR BEFORE USE IF
• ASK DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
• WHEN USING THIS PRODUCT
• STOP USE AND ASK A DOCTOR IF
• KEEP OUT OF REACH OF CHILDREN
• DIRECTIONS
• INACTIVE INGREDIENT
• QUESTIONS?
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT

(in each 5 mL = 1 teaspoon)

Ibuprofen, USP 100 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

temporarily:

• •relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
• •reduces fever

WARNINGS

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child:

• •has had stomach ulcers or bleeding problems
• •takes a blood thinning (anticoagulant) or steroid drug
• •takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• •takes more or for a longer time than directed

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

DO NOT USE

• •if the child has ever had an allergic reaction to any other pain reliever/fever reducer
• •right before or after heart surgery

ASK DOCTOR BEFORE USE IF

• •stomach bleeding warning applies to your child
• •child has a history of stomach problems, such as heartburn
• •child has problems or serious side effects from taking pain relievers or fever reducers
• •child has not been drinking fluids
• •child has lost a lot of fluid due to vomiting or diarrhea
• •child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
• •child has asthma
• •child is taking a diuretic

ASK DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

• •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

• •child experiences any of the following signs of stomach bleeding
• •feels faint
• •vomits blood
• •has bloody or black stools
• •has stomach pain that does not get better
• •the child does not get any relief within the first day (24 hours) of treatment
• •fever or pain gets worse or lasts more than 3 days
• •redness or swelling is present in the painful area
• •any new symptoms appear

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

• • this product does not contain directions or complete warnings for adult use
• • do not give more than directed
• • shake well before using
• •find right dose on chart.  If possible, use weight to dose; otherwise use age.
• •use only enclosed measuring cup
• •if needed, repeat dose every 6-8 hours
• •do not use more than 4 times a day
• •replace original bottle cap to maintain child resistance

Other information

• •each teaspoon contains: sodium 2 mg
• • do not use if printed neckband is broken or missing
• •store between 20 - 25°C (68 - 77°F)
• •see bottom panel for lot number and expiration date

INACTIVE INGREDIENT

Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

Dye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

QUESTIONS?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Children’s Motrin( Berry*)

NDC 68788-9109-1

For ages 2 to 11

CHILDREN’S Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL (teaspoon)

Pain Reliever

Fever Reducer

Lasts up to 8 hours

Original Berry Flavor

Alcohol Free

4 FL OZ (118 mL)

12550112L1 VC100602