Family Wellness children's Ibuprofen Oral Suspension 572

Family Wellness children's Ibuprofen Oral Suspension 572
SPL v2
SPL
SPL Set ID 1a2182df-4339-442d-9c61-98c8b01e36fa
Route
ORAL
Published
Effective Date 2025-12-03
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Polysorbate 80 Starch, Pregelatinized Corn Water Sodium Benzoate Sucrose Xanthan Gum

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-04-18

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

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