CHILDRENS IBUPROFEN- ibuprofen suspension 
Walgreens

----------

Ibuprofen Oral Suspension, USP

Drug Facts

 

Active ingredient

(in each 5 mL)
Ibuprofen, USP 100 mg (NSAID)**
**nonsteroidal anti-inflammatory drug

Purpose 

Pain reliever/fever reducer

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.

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

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

Ask a doctor or pharmacist before use if the child is

• under a doctor’s care for any serious condition
• taking any other drug

When using this product

• take with food or milk if stomach upset occurs

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

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 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL
36-47 lbs4-5 years7.5 mL
48-59 lbs6-8 years10 mL
60-71 lbs9-10 years12.5 mL
72-95 lbs11 years15 mL
*or as directed by a doctor

Other information

each 5 mL contains: sodium 2 mg
• store between 20° to 25°C (68° to 77°F)
• do not use if printed neckband is broken or missing
• see bottom panel for lot number and expiration date

Inactive ingredients

Blue Raspberry: acesulfame potassium, citric acid anhydrous, FD&C blue #1, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, artificial raspberry 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

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

Bubble Gum: acesulfame potassium, artificial bubble gum flavor, citric acid anhydrous, 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

Questions?

1-888-838-2872 between 9 am and 5 pm, ET Monday–Friday.

PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Children’s Motrin® active ingredient

SEE NEW WARNINGS

FOR AGES 2 TO 11 YEARS

children’s
Ibuprofen
100
IBUPROFEN
ORAL SUSPENSION, USP
(NSAID)
100 mg PER 5 mL 

PAIN RELIEVER / FEVER REDUCER

LASTS UP TO 8 HOURS

ALCOHOL FREE

AGES 2-11 YEARS

BLUE RASPBERRY FLAVOR

Shake well before using

4 FL OZ (118 mL)

Children's Ibuprofen - Blue Raspberry

PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Children’s Motrin® Dye-Free Berry active ingredient

SEE NEW WARNINGS

FOR AGES 2 TO 11 YEARS

children’s
Dye-Free
Ibuprofen 100
IBUPROFEN
ORAL SUSPENSION, USP
(NSAID)
100 mg PER 5 mL 

PAIN RELIEVER /
FEVER REDUCER

DYE FREE

LASTS UP TO 8 HOURS

ALCOHOL FREE

● Non-staining

AGES 2-11 YEARS

BERRY FLAVOR

Shake well before using

4 FL OZ (118 mL)

image

PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Children’s Motrin® Grape active ingredient

SEE NEW WARNINGS

FOR AGES 2 TO 11 YEARS

children’s
Ibuprofen
100
IBUPROFEN
ORAL SUSPENSION, USP
(NSAID)
100 mg PER 5 mL 

PAIN RELIEVER / FEVER REDUCER

LASTS UP TO 8 HOURS

ALCOHOL FREE

AGES 2-11 YEARS

GRAPE FLAVOR

Shake well before using

4 FL OZ (118 mL)

image

PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Children’s Motrin® active ingredient

SEE NEW WARNINGS

FOR AGES 2 TO 11 YEARS

children’s
Ibuprofen
100
IBUPROFEN
ORAL SUSPENSION, USP
(NSAID)
100 mg PER 5 mL 

PAIN RELIEVER / FEVER REDUCER

LASTS UP TO 8 HOURS

ALCOHOL FREE

AGES 2-11 YEARS

BUBBLE GUM FLAVOR

Shake well before using

4 FL OZ (118 mL)

image

PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Children’s Motrin® active ingredient

SEE NEW WARNINGS

FOR AGES 2 TO 11 YEARS

children’s
Ibuprofen
100
IBUPROFEN
ORAL SUSPENSION, USP
(NSAID)
100 mg PER 5 mL 

PAIN RELIEVER / FEVER REDUCER

LASTS UP TO 8 HOURS

ALCOHOL FREE

AGES 2-11 YEARS

ORIGINAL
BERRY FLAVOR

Shake well before using

4 FL OZ (118 mL)

image
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1764
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorRASPBERRY (blue raspberry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1764-941 in 1 CARTON08/01/2016
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491608/01/201612/31/2021
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1761
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorwhite ((opaque)) Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1761-941 in 1 CARTON02/01/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491602/01/201812/31/2021
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1762
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1762-941 in 1 CARTON03/02/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491603/02/201812/31/2021
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1763
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1763-941 in 1 CARTON03/02/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491603/02/201812/31/2021
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7610
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-7610-941 in 1 CARTON02/27/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491602/27/201812/31/2021
Labeler - Walgreens (008965063)

Revised: 11/2021
 
Walgreens