CHILDRENS IBUPROFEN  - ibuprofen suspension 
Actavis Mid Atlantic LLC

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ACTIVE INGREDIENT

Active ingredient (in each 5 mL = 1 teaspoon)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

temporarily:

WARNINGS

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.

The chances are higher if your child:

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:

ASK DOCTOR BEFORE USE IF:

ASK DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS:

WHEN USING THIS PRODUCT:

STOP USE AND ASK A DOCTOR IF:

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).

DIRECTIONS

Dosing Chart
Weight (lb)Age (yr)Dose (tsp or mL)
under 2 yearsask a doctor
24 – 35 lbs2 – 3 years1 tsp or 5 mL
36 – 47 lbs4 – 5 years1½ tsp or 7.5 mL
48 – 59 lbs6 – 8 years2 tsp or 10 mL
60 – 71 lbs9 – 10 years2½ tsp or 12.5 mL
72 – 95 lbs11 years3 tsp or 15 mL

Other information

INACTIVE INGREDIENTS

Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.

Dye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.

Grape flavor: citric acid, D&C red #33, FD&C blue #1, FD&C Red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40,  glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.

QUESTIONS

1-800-432-8534 (select option # 2) between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

NDC 0472-1255-94

For ages 2 to 11

CHILDREN’S Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL (teaspoon)

Pain Reliever

Fever Reducer

Lasts up to 8 hours

See New Warnings Information

Original Berry Flavor

Alcohol Free

4 FL OZ (118 mL)

T:\Maryland\NJ\Juan\Childrens Ibuprofen\ANDA 074916\labels\1255_vc109684.jpg

ORIGINAL BERRY FLAVOR CARTON LABEL

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

NDC 0472-1261-94

For ages 2 to 11

CHILDREN’S Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL (teaspoon)

Pain Reliever

Fever Reducer

Lasts up to 8 hours

See New Warnings Information

Non-Staining

Dye-Free Berry Flavor

Alcohol Free

4 FL OZ (118 mL)

T:\Maryland\NJ\Juan\Childrens Ibuprofen\ANDA 074916\labels\1261_vc109686.jpg

DYE FREE BERRY FLAVOR CARTON LABEL

Compare to the active ingredient in Children’s Motrin® Grape*

NDC 0472-1262-94

For ages 2 to 11

CHILDREN’S Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL (teaspoon)

Pain Reliever

Fever Reducer

Lasts up to 8 hours

See New Warnings Information

Grape Flavor

Alcohol Free

4 FL OZ (118 mL)

T:\Maryland\NJ\Juan\Childrens Ibuprofen\ANDA 074916\labels\1262_vc109687.jpg

GRAPE FALVOR CARTON LABEL

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

NDC 0472-1263-94

For ages 2 to 11

CHILDREN’S Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL (teaspoon)

Pain Reliever

Fever Reducer

Lasts up to 8 hours

See New Warnings Information

Bubble Gum Flavor

Alcohol Free

4 FL OZ (118 mL)

T:\Maryland\NJ\Juan\Childrens Ibuprofen\ANDA 074916\labels\1263_vc109685.jpg

BUBBLE GUM FLAVOR CARTON LABEL


CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1255
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSES 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorORANGE (red) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0472-1255-941 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1118 mL in 1 BOTTLEThis package is contained within the CARTON (0472-1255-94)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491606/01/2006

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1261
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
HYPROMELLOSES 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0472-1261-941 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1118 mL in 1 BOTTLEThis package is contained within the CARTON (0472-1261-94)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491606/01/2006

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1262
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSES 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0472-1262-941 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1118 mL in 1 BOTTLEThis package is contained within the CARTON (0472-1262-94)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491606/01/2006

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1263
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSES 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorPINK (light) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0472-1263-941 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1118 mL in 1 BOTTLEThis package is contained within the CARTON (0472-1263-94)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491606/01/2006

Labeler - Actavis Mid Atlantic LLC (809515898)

Revised: 05/2010 Actavis Mid Atlantic LLC