DYE FREE CHILDRENS IBUPROFEN- ibuprofen suspension

Dye Free Childrens Ibuprofen by

Drug Labeling and Warnings

Dye Free Childrens Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Precision Dose Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Berry Flavor

100 mg/5 mL

For Hospital Use Only

Drug Facts
Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)1

1 nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily:

relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
reduces fever
Important: Read all product information before using.
This product is intended for use in children.

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

use as directed per healthcare professional
this product does not contain directions or complete warnings for adult use
do not give more than directed
shake well before using
mL = milliliter; tsp = teaspoonful
find right dose on chart. If possible, use weight to dose; otherwise use age.
if needed, repeat dose every 6-8 hours
do not use more than 4 times a day

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

each 5 mL (1 tsp) contains: sodium 2 mg
store at 20-25°C (68-77°F)
do not freeze
see individual label or shipper for lot number and expiration date

Inactive ingredients

anhydrous citric acid, artificial mixed berry flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

SPL UNCLASSIFIED SECTION

Alcohol Free, Dye Free, Gluten Free

How Supplied

NDC: 68094-600-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC: 68094-600-62
5 mL per unit dose cup
Thirty (30) cups per shipper

SPL UNCLASSIFIED SECTION

Distributed By
Perrigo Company
Allegan, MI 49010

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

LI 979 Rev. 03/17

PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Cup Label

NDC: 68094-600-59
PrecisionDose™

Children's IBUPROFEN
Oral Suspension
100 mg/5 mL

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

Principal Display Panel - 100 mg/5 mL Cup Label

INGREDIENTS AND APPEARANCE

DYE FREE CHILDRENS IBUPROFEN
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68094-600(NDC:0113-0685)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)	Ibuprofen	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Anhydrous citric acid (UNII: XF417D3PSL)
Glycerin (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
polysorbate 80 (UNII: 6OZP39ZG8H)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
xanthan gum (UNII: TTV12P4NEE)
high fructose corn syrup (UNII: XY6UN3QB6S)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 68094-600-62	3 in 1 CASE	08/26/2015
1		10 in 1 TRAY
1	NDC: 68094-600-59	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 68094-600-61	10 in 1 CASE	08/26/2015
2		10 in 1 TRAY
2	NDC: 68094-600-59	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074937	08/26/2015

Labeler - Precision Dose Inc. (035886746)