Children's Ibuprofen Oral Suspension

Drug Facts

Composition & Product

Active Ingredients

Ibuprofen (100 mg)

Inactive Ingredients

Anhydrous Citric Acid Glycerin Polysorbate 80 Starch, Pregelatinized Corn Water Sodium Benzoate Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

ANDA Active Since 2025-02-13

Medication Information

Purpose

Pain reliever/fever reducer

Description

Ibuprofen, USP 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Use(s)

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
asthma (wheezing)
skin reddening
facial swelling
shock
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 you 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.

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.

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL)*
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL
36-47 lbs	4-5 years	7.5 mL
48-59 lbs	6-8 years	10 mL
60-71 lbs	9-10 years	12.5 mL
72-95 lbs	11 years	15 mL

*or as directed by a 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

Other Information

each 5 mL contains: sodium 2 mg
store between 20-25^oC (68-77^oF)
do not use if carton is opened or if printed inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing.

Inactive Ingredients

anhydrous citric acid, flavor, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

Questions Or Comments?

call 1-609-860-2600 (Monday - Friday 8:00 am - 4:30 pm EST)

Principal Display Panel

Compare to Children's Motrin^® active ingredient*

NDC 53943-682-03

DISCOUNT drug mart

FOOD FAIR

Dye Free

Children's

Ibuprofen

Oral Suspension, USP (NSAID)

100 mg per 5 mL

Pain Reliever/Fever Reducer

Lasts up to 8 Hours
No Artificial Sweetener
Alcohol Free

Mixed Berry Flavor

4 FL OZ (120 mL)

When Using This Product

take with food or milk if stomach upset occurs

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

Stop Use and Ask 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 the 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)

Active Ingredient (in Each 5 Ml)

Ibuprofen, USP 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If the Child Is

under a doctor's care for any serious condition
taking any other drug

Structured Label Content

Use(s) (USE(S))

temporarily:

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

Purpose (PURPOSE)

Pain reliever/fever reducer

Warnings (WARNINGS)

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

hives
asthma (wheezing)
skin reddening
facial swelling
shock
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 you 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.

Directions (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.

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL)*
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL
36-47 lbs	4-5 years	7.5 mL
48-59 lbs	6-8 years	10 mL
60-71 lbs	9-10 years	12.5 mL
72-95 lbs	11 years	15 mL

*or as directed by a doctor

Do Not Use (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

Other Information (OTHER INFORMATION)

each 5 mL contains: sodium 2 mg
store between 20-25^oC (68-77^oF)
do not use if carton is opened or if printed inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing.

Inactive Ingredients (INACTIVE INGREDIENTS)

anhydrous citric acid, flavor, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call 1-609-860-2600 (Monday - Friday 8:00 am - 4:30 pm EST)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to Children's Motrin^® active ingredient*

NDC 53943-682-03

DISCOUNT drug mart

FOOD FAIR

Dye Free

Children's

Ibuprofen

Oral Suspension, USP (NSAID)

100 mg per 5 mL

Pain Reliever/Fever Reducer

Lasts up to 8 Hours
No Artificial Sweetener
Alcohol Free

Mixed Berry Flavor

4 FL OZ (120 mL)

When Using This Product (WHEN USING THIS PRODUCT)

take with food or milk if stomach upset occurs

Ask A Doctor Before Use If (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

Stop Use and Ask Doctor If (STOP USE AND ASK 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 the 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)

Active Ingredient (in Each 5 Ml) (ACTIVE INGREDIENT (in each 5 mL))

Ibuprofen, USP 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If the Child Is (ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS)

under a doctor's care for any serious condition
taking any other drug

Advanced Ingredient Data

[{"name": "IBUPROFEN", "unii": "WK2XYI10QM", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, PREGELATINIZED CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever", "PURPOSE": "Pain reliever/fever reducer", "WARNINGS": "Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) skin reddening facial swelling shock 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 you 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.", "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. Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL *or as directed by a 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", "OTHER INFORMATION": "each 5 mL contains: sodium 2 mg store between 20-25 o C (68-77 o F) do not use if carton is opened or if printed inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing.", "INACTIVE INGREDIENTS": "anhydrous citric acid, flavor, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum", "QUESTIONS OR COMMENTS?": "call 1-609-860-2600 (Monday - Friday 8:00 am - 4:30 pm EST)", "PRINCIPAL DISPLAY PANEL": "Compare to Children's Motrin ® active ingredient* NDC 53943-682-03 DISCOUNT drug mart FOOD FAIR Dye Free Children's Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL Pain Reliever/Fever Reducer Lasts up to 8 Hours No Artificial Sweetener Alcohol Free Mixed Berry Flavor 4 FL OZ (120 mL)", "WHEN USING THIS PRODUCT": "take with food or milk if stomach upset occurs", "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", "STOP USE AND ASK 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 the 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)", "ACTIVE INGREDIENT (in each 5 mL)": "Ibuprofen, USP 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug", "ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS": "under a doctor's care for any serious condition taking any other drug"}