CHILDRENS IBUPROFEN - ibuprofen suspension 
Preferred Pharmaceuticals, Inc

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Children’s Ibuprofen Oral Suspension, USP

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:

  • 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.

The chances are 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 DOCTOR BEFORE USE IF:

  • stomach bleeding warning applies to your child
  • child has a history of stomach problems, such as heartburn
  • 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 is taking a diuretic

ASK 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
  • 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 the 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

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
  • Find right dose on chart below.  If possible, use weight to dose; otherwise use age.
  • Use only enclosed measuring cup
  • 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 (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

  • do not use if printed neckband is broken or missing
  • store between 20 - 25°C (68 - 77°F)
  • see bottom panel for lot number and expiration date

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.

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 68788-9109-1

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

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68788-9109(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 DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9109-11 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491606/01/2006
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022relabel

Revised: 5/2010
 
Preferred Pharmaceuticals, Inc