Family Wellness children's Ibuprofen Oral Suspension 572
1a2182df-4339-442d-9c61-98c8b01e36fa
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Ibuprofen, USP 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
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 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
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.
- 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
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 20-25oC (68-77oF)
- 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, FD&C red no. 40, flavor, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum.
Questions Or Comments?
Call 1-609-860-2600 (Monday-Friday 8 am -4 pm)
Principal Display Panel
FAMILY Wellness
COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S MOTRIN®*
Children's Ibuprofen
Oral Suspension
Ages 2 to 11 Years
USP 100 mg per 5 mL
Pain Reliever/Fever Reducer
(NSAID)
8 Hour
Alcohol Free
BUBBLE GUM FLAVOR
4 FL OZ (120mL)
When Using This Product
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer 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 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
- 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 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
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.
- 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
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 20-25oC (68-77oF)
- 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, FD&C red no. 40, 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 am -4 pm)
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
FAMILY Wellness
COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S MOTRIN®*
Children's Ibuprofen
Oral Suspension
Ages 2 to 11 Years
USP 100 mg per 5 mL
Pain Reliever/Fever Reducer
(NSAID)
8 Hour
Alcohol Free
BUBBLE GUM FLAVOR
4 FL OZ (120mL)
When Using This Product (WHEN USING THIS PRODUCT)
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer 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 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
- 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
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:25.840885 · Updated: 2026-03-14T23:10:51.714911