CHILDRENS IBUPROFEN- ibuprofen suspension 
Precision Dose Inc.

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CHILDREN'S IBUPROFEN ORAL SUSPENSION

Berry Flavor

100 mg/5 mL  200 mg/10 mL

For Hospital Use Only

Drug Facts

Active ingredient (in each 5 mL)

Ibuprofen 100 mg (NSAID)1


1
nonsteroidal anti-inflammatory drug

Purposes

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:

  • 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

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 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, or kidney disease
  • 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

  • give 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

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
  • 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

Dosing Chart
Weight (lb) Age (yr) Dose (mL or tsp)*
*
or as directed by a doctor
Under 24 lbs Under 2 years Ask a doctor
24-35 lbs 2-3 years 5 mL (1 tsp)
36-47 lbs 4-5 years 7.5 mL (1½ tsp)
48-59 lbs 6-8 years 10 mL (2 tsp)
60-71 lbs 9-10 years 12.5 mL (2½ tsp)
72-95 lbs 11 years 15 mL (3 tsp)

Other information

Inactive ingredients

anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Alcohol Free, Gluten Free

How Supplied

NDC 68094-494-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-494-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-494-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-503-61
10 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-503-62
10 mL per unit dose cup
Thirty (30) cups per shipper

Distributed By
Perrigo Company
Allegan, MI 49010

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

LI587   Rev. 06/17

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC# 68094-494-58

Children's IBUPROFEN Oral Suspension, 100 mg/5 mL

Delivers 5 mL
(NSAID)
For Hospital Use Only

Each 5 mL contains: sodium 2 mg

Alcohol Free
Gluten Free

Store at 20°-25°C (68°-77°F)
Protect from freezing

Pkg: Precision Dose, Inc. S. Beloit, IL 61080

LSY495 Rev. 04/11

For Oral Use Only

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PRINCIPAL DISPLAY PANEL - 200 mg/10 mL Lid

NDC 68094-503-59

PrecisionDoseā„¢

Children's IBUPROFEN
Oral Suspension
200 mg/10 mL

Delivers 10 mL Shake Well (NSAID) Alcohol Free Gluten Free
Each 5 mL contains: sodium 2 mg

Hospital Use Only
Store at 20-25°C (68-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 200 mg/10 mL Lid
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-494
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid (UNII: XF417D3PSL)  
D&C yellow NO. 10 (UNII: 35SW5USQ3G)  
FD&C red NO. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
high fructose corn syrup (UNII: XY6UN3QB6S)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
Color ORANGE Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68094-494-62 3 in 1 CASE 04/13/2004
1 10 in 1 TRAY
1 NDC:68094-494-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2 NDC:68094-494-61 10 in 1 CASE 04/13/2004
2 10 in 1 TRAY
2 NDC:68094-494-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3 NDC:68094-494-58 5 in 1 CASE 04/13/2004
3 10 in 1 BAG
3 5 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074937 04/13/2004
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-503
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 200 mg  in 10 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid (UNII: XF417D3PSL)  
D&C yellow NO. 10 (UNII: 35SW5USQ3G)  
FD&C red NO. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
high fructose corn syrup (UNII: XY6UN3QB6S)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
Color ORANGE Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68094-503-62 3 in 1 CASE 09/14/2006
1 10 in 1 TRAY
1 NDC:68094-503-59 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2 NDC:68094-503-61 10 in 1 CASE 09/14/2006
2 10 in 1 TRAY
2 NDC:68094-503-59 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074937 09/14/2006
Labeler - Precision Dose Inc. (035886746)
Establishment
Name Address ID/FEI Business Operations
L. Perrigo Company 006013346 MANUFACTURE(68094-494, 68094-503)

Revised: 10/2017
Document Id: c025931c-2a24-417d-9e75-ec2947ecbe3b
Set id: 1984374e-7639-4a4f-bf96-a614e663e0c4
Version: 5
Effective Time: 20171023
 
Precision Dose Inc.