Children's Ibuprofen Oral Suspension

SPL v10

SPL

SPL Set ID 9291857c-30b3-414b-99e1-9c127e72c0d4

Route

ORAL

Published

Effective Date 2025-08-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ibuprofen (100 mg)

Inactive Ingredients

Anhydrous Citric Acid D&c Yellow No. 10 Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Hypromellose, Unspecified Polysorbate 80 Water Sodium Benzoate Sorbitol Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: orange

Marketing Status

ANDA Active Since 2004-04-13

Description

Berry Flavor 100 mg/5 mL 200 mg/10 mL For Hospital Use Only LI1651 Rev. 02/25 Drug Facts

Purpose

Pain reliever/fever reducer

How Supplied

Overbagged with 5 x 5 mL unit dose cups in each bag, NDC 55154-1577-5 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Medication Information

Purpose

Pain reliever/fever reducer

How Supplied

Overbagged with 5 x 5 mL unit dose cups in each bag, NDC 55154-1577-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Description

Berry Flavor 100 mg/5 mL 200 mg/10 mL For Hospital Use Only LI1651 Rev. 02/25 Drug Facts

Uses

temporarily:

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

Section 42229-5

Berry Flavor

100 mg/5 mL 200 mg/10 mL

For Hospital Use Only

LI1651 Rev. 02/25

Drug Facts

Section 50565-1

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)

Purposes

Pain reliever/fever reducer

Directions

▪
Use as directed per healthcare professional.
▪
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.
▪
if needed, repeat dose every 6-8 hours
▪
do not use more than 4 times a day

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL) or as directed by a doctor
under 24 lbs	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

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

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.

Other Information

▪
each 5 mL contains: sodium 2 mg
▪
store at 20-25°C (68-77°F)
▪
do not freeze

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.

Inactive Ingredients

anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions Or Comments?

1-800-397-9228

Principal Display Panel

NDC 55154-1577-5

CHILDREN’S IBUPROFEN ORAL

SUSPENSION

100 mg/5 mL

5 UNIT DOSE CUPS

When Using This Product

▪
give with food or milk if stomach upset occurs

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

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 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

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.

Active Ingredient (in Each 5 Ml)

Ibuprofen 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

Uses

temporarily:

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

Section 42229-5 (42229-5)

Berry Flavor

100 mg/5 mL 200 mg/10 mL

For Hospital Use Only

LI1651 Rev. 02/25

Drug Facts

Section 50565-1 (50565-1)

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)

Purposes

Pain reliever/fever reducer

Directions

▪
Use as directed per healthcare professional.
▪
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.
▪
if needed, repeat dose every 6-8 hours
▪
do not use more than 4 times a day

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL) or as directed by a doctor
under 24 lbs	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

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

How Supplied

Overbagged with 5 x 5 mL unit dose cups in each bag, NDC 55154-1577-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Allergy Alert (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.

Other Information (Other information)

▪
each 5 mL contains: sodium 2 mg
▪
store at 20-25°C (68-77°F)
▪
do not freeze

Sore Throat Warning (Sore throat warning)

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-800-397-9228

Principal Display Panel

NDC 55154-1577-5

CHILDREN’S IBUPROFEN ORAL

SUSPENSION

100 mg/5 mL

5 UNIT DOSE CUPS

When Using This Product (When using this product)

▪
give with food or milk if stomach upset occurs

Stomach Bleeding Warning (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

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 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

Heart Attack and Stroke Warning (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.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Ibuprofen 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

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily: ▪ relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache ▪ reduces fever", "42229-5": "Berry Flavor 100 mg/5 mL 200 mg/10 mL For Hospital Use Only LI1651 Rev. 02/25 Drug Facts", "50565-1": "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)", "Purposes": "Pain reliever/fever reducer", "Directions": "▪ Use as directed per healthcare professional. ▪ 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. ▪ if needed, repeat dose every 6-8 hours ▪ do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Dose (mL) or as directed by a doctor under 24 lbs 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", "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", "How Supplied": "Overbagged with 5 x 5 mL unit dose cups in each bag, NDC 55154-1577-5 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.", "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.", "Other information": "▪ each 5 mL contains: sodium 2 mg ▪ store at 20-25°C (68-77°F) ▪ do not freeze", "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.", "Inactive ingredients": "anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum", "Questions or comments?": "1-800-397-9228", "Principal Display Panel": "NDC 55154-1577-5 CHILDREN’S IBUPROFEN ORAL SUSPENSION 100 mg/5 mL 5 UNIT DOSE CUPS", "When using this product": "▪ give with food or milk if stomach upset occurs", "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", "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 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", "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.", "Active ingredient (in each 5 mL)": "Ibuprofen 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:53.136688 · Updated: 2026-03-14T23:09:55.704959