Childrens Ibuprofen Oral Suspension
099e374b-49c2-4d56-a047-d4f0c4af34ba
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts Active ingredient (in each 5 mL) Ibuprofen, USP 100 mg (NSAID)** **nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Drug Facts Active ingredient (in each 5 mL) Ibuprofen, USP 100 mg (NSAID)** **nonsteroidal anti-inflammatory drug
Uses
temporarily:
- relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
- reduces fever
Section 55106-9
Drug Facts
Active ingredient (in each 5 mL)
Ibuprofen, USP 100 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Warnings
Allergy alert: Ibuprofen may cause 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 drug 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 a 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.
- 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 | 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 20º to 25ºC (68º to 77ºF)
- do not use if printed neckband is broken or missing
Inactive Ingredients
Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum
Questions Or Comments?
Call 1-888-588-1418 from 9 AM to 5 PM ET, Monday-Friday.
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
Principal Display Panel List
NDC 81522-311-11
†Compare to the active ingredient in Children's Motrin®
FOR AGES 2-11 YEARS
CHILDREN'S IBUPROFEN
100 mg per 5 mL
Oral Suspension, USP (NSAID)
PAIN RELIEVER/FEVER REDUCER
ORIGINAL Berry Flavor
- Dye-Free
- Alcohol-Free
Lasts up to 8 HOURS
4 FL OZ (118mL)
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®.
Manufactured for FSA Store Inc.
5473 Blair Rd Suite 100
PMB 24308 Dallas, TX 75231
res
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 stool
- 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)
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 55106-9 (55106-9)
Drug Facts
Active ingredient (in each 5 mL)
Ibuprofen, USP 100 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Warnings
Allergy alert: Ibuprofen may cause 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 drug 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 a 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.
- 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 | 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 20º to 25ºC (68º to 77ºF)
- do not use if printed neckband is broken or missing
Inactive Ingredients (Inactive ingredients)
Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum
Questions Or Comments? (Questions or comments?)
Call 1-888-588-1418 from 9 AM to 5 PM ET, Monday-Friday.
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
Principal Display Panel List (Principal display panel list)
NDC 81522-311-11
†Compare to the active ingredient in Children's Motrin®
FOR AGES 2-11 YEARS
CHILDREN'S IBUPROFEN
100 mg per 5 mL
Oral Suspension, USP (NSAID)
PAIN RELIEVER/FEVER REDUCER
ORIGINAL Berry Flavor
- Dye-Free
- Alcohol-Free
Lasts up to 8 HOURS
4 FL OZ (118mL)
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®.
Manufactured for FSA Store Inc.
5473 Blair Rd Suite 100
PMB 24308 Dallas, TX 75231
res
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 stool
- 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)
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
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Source: dailymed · Ingested: 2026-02-15T12:07:02.591735 · Updated: 2026-03-14T23:10:13.362427