Children's Ibuprofen Oral Suspension

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

If an allergic reaction occurs, stop use and seek medical

help right away.

Stomach bleeding warning:This product contains an

NSAlD, 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

Heart attack and stroke warning:NSAlDs, except

aspirin, increase the risk of heart attack, heart failure, and

stroke. These can be fatal. The risk is higher if you use

more than directed or for longer 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.

Uses temporarily:

■ relieves minor aches and pains due to the common cold, flu, sore throat,

   headache and toothache

■ reduces fever

Directions

■ this product does not contain directions or

   complete warnings for adult use

■ do not give more than directed

■ shake well before using

■ mL= milliliter

■ find right dose on chart. If possible, use weight to

   dose; otherwise use age.

■ use only enclosed dosing cup. Do not use any other

   dosing device.

■ 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

                                       Dosing Chart

*or as directed by a doctor

Drug Facts

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)

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

■ child has symptoms of heart problems or stroke:

  ■ chest pain            ■ trouble breathing

  ■ weakness in one part or side of body

  ■ slurred speech      ■ leg swelling

■ the child does not get any relief within 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

When using this product

■ take with food or milk if stomach upset occurs

Ask a doctor or pharmacist before use if the child is

■ under a doctor's care for any serious condition

■ taking any other drug

Ask a 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, kidney disease, or had a stroke

■ child has asthma

■ child is taking a diuretic

Do not use

■ If the child has ever had an allergic reaction to Ibuprofen

   or any other pain reliever/fever reducer

■ right before or after heart surgery

Inactive ingredients

Acesulfame potassium, anhydrous citric acid,

carboxymethylcellulose sodium, D&C Yellow #10, FD&C

Red #40, flavors, glycerin, microcrystalline cellulose,

polysorbate 80, propylene glycol, purified water, sodium

benzoate, sucrose, and xanthan gum

Questions or comments?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-732-314-4550

Purpose

Pain reliever/

fever reducer

Active ingredient

(in each 5 mL)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Other information

■  each 5 mL contains:sodium 2 mg

■ store between 20-25° C (68-77° F)

■  do not use if carton is opened or printed bottle

   neckband is broken or missing

■ see bottom panel for lot number and expiration date

PURO                            NDC 83474-002-04

PHARMA

COMPARE TO THE

ACTIVE INGREDIENT

IN CHILDREN'S

MOTRIN ^®**

Children's

Ibuprofen

Oral Suspension (NSAID)

100 mg per 5 ml

FOR AGES 2 TO 11 YEARS

Pain Reliever

Fever Reducer

LASTS UP TO 8 HOURS

Original

Berry Flavor

4 FL OZ (11 8 mL)

Important Read all product information before using.

Keep this box for important information.

This product is intended for use in children.

**This product is not manufactured or distributed by McNeil

Consumer Healthcare, distributor of Children's Motrin ^®

Distributed by:

Puro Pharma Inc.

42 Catharine St. Poughkeepsie, NY 12601

[email protected]

BX-174

res

Uses temporarily:

■ relieves minor aches and pains due to the common cold, flu, sore throat,

   headache and toothache

■ reduces fever

Directions

■ this product does not contain directions or

   complete warnings for adult use

■ do not give more than directed

■ shake well before using

■ mL= milliliter

■ find right dose on chart. If possible, use weight to

   dose; otherwise use age.

■ use only enclosed dosing cup. Do not use any other

   dosing device.

■ 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

                                       Dosing Chart

*or as directed by a doctor

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

If an allergic reaction occurs, stop use and seek medical

help right away.

Stomach bleeding warning:This product contains an

NSAlD, 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

Heart attack and stroke warning:NSAlDs, except

aspirin, increase the risk of heart attack, heart failure, and

stroke. These can be fatal. The risk is higher if you use

more than directed or for longer 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.

Drug Facts

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)

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

■ child has symptoms of heart problems or stroke:

  ■ chest pain            ■ trouble breathing

  ■ weakness in one part or side of body

  ■ slurred speech      ■ leg swelling

■ the child does not get any relief within 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

When using this product

■ take with food or milk if stomach upset occurs

Ask a doctor or pharmacist before use if the child is

■ under a doctor's care for any serious condition

■ taking any other drug

Ask a 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, kidney disease, or had a stroke

■ child has asthma

■ child is taking a diuretic

Do not use

■ If the child has ever had an allergic reaction to Ibuprofen

   or any other pain reliever/fever reducer

■ right before or after heart surgery

Inactive ingredients

Acesulfame potassium, anhydrous citric acid,

carboxymethylcellulose sodium, D&C Yellow #10, FD&C

Red #40, flavors, glycerin, microcrystalline cellulose,

polysorbate 80, propylene glycol, purified water, sodium

benzoate, sucrose, and xanthan gum

Questions or comments?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-732-314-4550

Purpose

Pain reliever/

fever reducer

Active ingredient

(in each 5 mL)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Other information

■  each 5 mL contains:sodium 2 mg

■ store between 20-25° C (68-77° F)

■  do not use if carton is opened or printed bottle

   neckband is broken or missing

■ see bottom panel for lot number and expiration date

PURO                            NDC 83474-002-04

PHARMA

COMPARE TO THE

ACTIVE INGREDIENT

IN CHILDREN'S

MOTRIN ^®**

Children's

Ibuprofen

Oral Suspension (NSAID)

100 mg per 5 ml

FOR AGES 2 TO 11 YEARS

Pain Reliever

Fever Reducer

LASTS UP TO 8 HOURS

Original

Berry Flavor

4 FL OZ (11 8 mL)

Important Read all product information before using.

Keep this box for important information.

This product is intended for use in children.

**This product is not manufactured or distributed by McNeil

Consumer Healthcare, distributor of Children's Motrin ^®

Distributed by:

Puro Pharma Inc.

42 Catharine St. Poughkeepsie, NY 12601

[email protected]

BX-174

res