Children's Ibuprofen Oral Suspension
f0959369-890e-403e-8a98-4eda340a0783
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Warnings and Precautions
Warnings
Allergy alert: Ibuprofen may cause asevere 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.
Indications and Usage
Uses
temporarily:
■ relieves minor aches and pains due to the common cold,
flu, sore throat, headache and toothache
■ reduces fever
Dosage and Administration
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
| 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 | 11years | 15 mL |
* or as directed by a doctor
Description
Drug Facts
Section 42229-5
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)
Section 50566-9
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
Section 50567-7
When using this product
■ take with food or milk if stomach upset occurs
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
Section 50569-3
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
Section 50570-1
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
Section 51727-6
Inactive ingredients
Acesulfame potassium, anhydrous citric acid,
carboxymethylcellulose sodium, D&C Red #33, FD&C Red
#40, flavors, glycerin, microcrystalline cellulose,
polysorbate 80, propylene glycol, purified water, sodium
benzoate, sucrose, and xanthan gum
Section 51945-4
children's
ibuprofen
Oral Suspension (NSAID)
For Ages 2 to 11 Years
NDC 63868-796-04
QC
QUALITY CHOICE See New Warnings
Compare to the
active ingredient in
Children's Motrin®**
children's
ibuprofen
Oral Suspension (NSAID)
100 mg per 5 mL
Pain Reliever/Fever Reducer
8 HRS Lasts up to
8 Hours
For ages 2 to 11 years
Alcohol Free
Bubble Gum
Flavor
4 fl oz (118 mL)
Important: Read all product indormation 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®.
BX-110
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
res
Section 53413-1
Questions or comments?
Call 732-314-4550 from 9AM to 5PM EST,
Monday - Friday.
Section 55105-1
Purpose
Ibuprofen .... Pain reliever/fever reducer
Section 55106-9
Active ingredient
(in each 5 mL)
Ibuprofen 100 mg (NSAlD)*
*nonsteroidal anti-inflammatory drug
Section 60561-8
Other information
■ each 5 mL contains: sodium 2 mg
■ store between 20-25ºC (68-77ºF)
■ do not use if carton is opened or printed bottle
neckband is broken or missing
■ see bottom panel for lot number and expiration date
Structured Label Content
Indications and Usage (34067-9)
Uses
temporarily:
■ relieves minor aches and pains due to the common cold,
flu, sore throat, headache and toothache
■ reduces fever
Dosage and Administration (34068-7)
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
| 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 | 11years | 15 mL |
* or as directed by a doctor
Warnings and Precautions (34071-1)
Warnings
Allergy alert: Ibuprofen may cause asevere 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.
Section 42229-5 (42229-5)
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)
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
When using this product
■ take with food or milk if stomach upset occurs
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
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
Inactive ingredients
Acesulfame potassium, anhydrous citric acid,
carboxymethylcellulose sodium, D&C Red #33, FD&C Red
#40, flavors, glycerin, microcrystalline cellulose,
polysorbate 80, propylene glycol, purified water, sodium
benzoate, sucrose, and xanthan gum
Section 51945-4 (51945-4)
children's
ibuprofen
Oral Suspension (NSAID)
For Ages 2 to 11 Years
NDC 63868-796-04
QC
QUALITY CHOICE See New Warnings
Compare to the
active ingredient in
Children's Motrin®**
children's
ibuprofen
Oral Suspension (NSAID)
100 mg per 5 mL
Pain Reliever/Fever Reducer
8 HRS Lasts up to
8 Hours
For ages 2 to 11 years
Alcohol Free
Bubble Gum
Flavor
4 fl oz (118 mL)
Important: Read all product indormation 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®.
BX-110
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
res
Section 53413-1 (53413-1)
Questions or comments?
Call 732-314-4550 from 9AM to 5PM EST,
Monday - Friday.
Section 55105-1 (55105-1)
Purpose
Ibuprofen .... Pain reliever/fever reducer
Section 55106-9 (55106-9)
Active ingredient
(in each 5 mL)
Ibuprofen 100 mg (NSAlD)*
*nonsteroidal anti-inflammatory drug
Section 60561-8 (60561-8)
Other information
■ each 5 mL contains: sodium 2 mg
■ store between 20-25ºC (68-77ºF)
■ do not use if carton is opened or printed bottle
neckband is broken or missing
■ see bottom panel for lot number and expiration date
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:02.414857 · Updated: 2026-03-14T23:06:20.316420