SPL v2
SPL
SPL Set ID 28dd9baa-43bd-b60a-e063-6394a90a8cf7
Route
ORAL
Published
Effective Date 2024-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Glycerin Anhydrous Citric Acid Sodium Benzoate Polysorbate 80 Acesulfame Sucrose Xanthan Gum D&c Yellow No. 10 Water Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-02

Description

Ibuprofen 100 mg (NSAID) 1 nonsteroidal anti-inflammatory drug


Medication Information

Description

Ibuprofen 100 mg (NSAID) 1 nonsteroidal anti-inflammatory drug

Section 50568-5

Ask a 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

Section 50569-3

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

Section 51727-6

acesulfame potassium, anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

Section 55105-1

Pain reliever/fever reducer

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 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

Heart attack and stroke warning

NSAIDs, 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.

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

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

Drug Facts

Ibuprofen 100 mg (NSAID) 1

nonsteroidal anti-inflammatory drug

Carton Label

Dosing Chart

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

Questions Or Comments

Call 1-516-341-0666 9AM-5 PM EST Monday - Friday

Principal Display Panel

NDC 69618-078-54

For Ages 2 to 11 Years

Children’s Ibuprofen Oral Suspension

Oral Suspension (NSAID)

100 mg per 5 mL

Pain Reliever / Fever Reducer

Lasts up to 8 hours

Dye Free

Original Berry Flavor

4 fl oz (118 mL)

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

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)


Structured Label Content

Section 50568-5 (50568-5)

Ask a 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

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

acesulfame potassium, anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

Section 55105-1 (55105-1)

Pain reliever/fever reducer

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 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

Heart attack and stroke warning

NSAIDs, 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.

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

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

Drug Facts

Ibuprofen 100 mg (NSAID) 1

nonsteroidal anti-inflammatory drug

Carton Label

Dosing Chart

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

Questions Or Comments (Questions or comments)

Call 1-516-341-0666 9AM-5 PM EST Monday - Friday

Principal Display Panel

NDC 69618-078-54

For Ages 2 to 11 Years

Children’s Ibuprofen Oral Suspension

Oral Suspension (NSAID)

100 mg per 5 mL

Pain Reliever / Fever Reducer

Lasts up to 8 hours

Dye Free

Original Berry Flavor

4 fl oz (118 mL)

Stop Use and Ask A Doctor If (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

Keep Out of Reach of Children (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)


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