Ibuprofen Oral Suspension, Usp

Ibuprofen Oral Suspension, Usp
SPL v10
SPL
SPL Set ID 89b9007e-49be-453f-a0ed-c572b56e0ad7
Route
ORAL
Published
Effective Date 2025-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Glycerin Polysorbate 80 Starch, Corn Water Sodium Benzoate Sucrose Xanthan Gum D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Color: purple Color: orange Color: white
Marketing Status
ANDA Active Since 2019-02-13

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

Uses

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                       
  • 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.

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 the 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 main 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

 125 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
Package Label
BEST CHOICE Children's Ibuprofen
Other Information
  • each 5 mL contains: sodium 2 mg
  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Grape: acesulfame potassium, artificial grape flavor, citric acid anhydrous, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum

Original Berry: acesulfame potassium, citric acid anhydrous, D&C yellow #10, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum

Dye-Free Berry: acesulfame potassium, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Children's Motrin®†

Children's Ibuprofen

Oral Suspension (NSAID)

100 mg per 5 mL

Pain Reliever/Fever Reducer

  • Alcohol Free

For ages 2 to 11 years

Lasta up to 8 hours

Grape Flavor

FL OZ (118 mL)

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®.

TAMPER EVIDENT: DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING.

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

500 KANSAS AVE

 



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
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
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Uses

temporarily:

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

     
Purpose

Pain reliever/fever reducer

Warnings

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.

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.

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 the 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 main 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

 125 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
Package Label (Package label)
BEST CHOICE Children's Ibuprofen
Other Information (Other information)
  • each 5 mL contains: sodium 2 mg
  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

Grape: acesulfame potassium, artificial grape flavor, citric acid anhydrous, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum

Original Berry: acesulfame potassium, citric acid anhydrous, D&C yellow #10, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum

Dye-Free Berry: acesulfame potassium, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel (Principal display panel)

Compare to the active ingredient in Children's Motrin®†

Children's Ibuprofen

Oral Suspension (NSAID)

100 mg per 5 mL

Pain Reliever/Fever Reducer

  • Alcohol Free

For ages 2 to 11 years

Lasta up to 8 hours

Grape Flavor

FL OZ (118 mL)

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®.

TAMPER EVIDENT: DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING.

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

500 KANSAS AVE

 



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
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
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 (1-800-222-1222) right away.

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)