IBUPROFEN CHILDRENS- ibuprofen suspension 
Actavis Pharma, Inc.

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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  
Age (yr)Dose (mL)*
under 2 yearsask a doctor
2-3 years5 mL
4-5 years7.5 mL
6-8 years10 mL
9-10 years12.5 mL
11 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

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

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

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

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

PRINCIPAL DISPLAY PANEL

Actavis

Compare to the active ingredient in Children’s Motrin® Berry† 

NDC 0472-1760-94

See New Warnings

For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL 

Pain Reliever
Fever Reducer 

Lasts up to 8 hours  

Shake Well
Before Using 

Original Berry Flavor 

Alcohol Free 

4 FL OZ (118 mL)

image

PRINCIPAL DISPLAY PANEL

Actavis

Compare to the active ingredient in Children’s Motrin® Dye Free Berry† 

NDC 0472-1761-94

See New Warnings

For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL 

Pain Reliever
Fever Reducer 

Lasts up to 8 hours  

Shake Well
Before Using 

Non-Staining
Dye-Free Berry Flavor 

Alcohol Free 

4 FL OZ (118 mL)

image

PRINCIPAL DISPLAY PANEL

Actavis

Compare to the active ingredient in Children’s Motrin® Bubble Gum† 

NDC 0472-1763-94

See New Warnings

For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL 

Pain Reliever
Fever Reducer 

Lasts up to 8 hours  

Shake Well
Before Using 

Bubble Gum Flavor 

Alcohol Free 

4 FL OZ (118 mL)

image

PRINCIPAL DISPLAY PANEL

Actavis

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

NDC 0472-1764-94

See New Warnings

For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL 

Pain Reliever
Fever Reducer 

Lasts up to 8 hours  

Shake Well
Before Using 

Blue Raspberry Flavor 

Alcohol Free 

4 FL OZ (118 mL)

image
IBUPROFEN  CHILDRENS
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1764
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:0472-1764-941 in 1 CARTON09/13/201610/31/2022
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491609/13/201610/31/2022
IBUPROFEN  CHILDRENS
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1760
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
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0472-1760-981 in 1 CARTON01/12/201809/30/2022
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0472-1760-941 in 1 CARTON02/21/201812/31/2021
2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491601/12/201809/30/2022
IBUPROFEN  CHILDRENS
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1763
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:0472-1763-941 in 1 CARTON03/06/201803/31/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491603/06/201803/31/2023
IBUPROFEN  CHILDRENS
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1761
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:0472-1761-941 in 1 CARTON04/12/201808/31/2022
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491604/12/201808/31/2022
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 12/2022
 
Actavis Pharma, Inc.