CHILDRENS IBUPROFEN- ibuprofen suspension 
Rugby Laboratories

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Ibuprofen Oral Suspension, USP

DRUG FACTS

ACTIVE INGREDIENT

(in each 5 mL = 1 teaspoon)

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
  • shock
  • asthma (wheezing)
  • rash
  • skin reddening
  • blisters
  • facial swelling

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 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 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

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.  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 years

 

 ask a doctor

 

 24 – 35 lbs

 

 2 – 3 years

 

 1 tsp or 5 mL

 

 36 – 47 lbs

 

 4 – 5 years

 

 1½ tsp or 7.5 mL

 

 48 – 59 lbs

 

 6 – 8 years

 

 2 tsp or 10 mL

 

 60 – 71 lbs

 

 9 – 10 years

 

 2½ tsp or 12.5 mL

 

 72 – 95 lbs

 

 11 years

 

 3 tsp or 15 mL

Other information

  • each teaspoon contains: sodium 2 mg
  • 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 INGREDIENT

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

QUESTIONS?

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

Generic Section

U.S. Patent No. 5,712,310

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Children’s Motrin®

12620112A1

VC112419

Made in USA

Distributed By:

RUGBY LABORATORIES

31778 Enterprise Drive, Livonia, MI 48150

www.rugbylaboratories.com

Rev. 03/15 Re-Order No. 370434 R-46

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

NDC 0536-1082-97

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

Grape Flavor

Alcohol Free

4 FL OZ (118 mL)

C:\Users\charlene.young\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.Outlook\1U3DRAJ6\Rugby - Children's Ibuprofen Oral Susp (Grape) -1082-97 Box 370434 (3-15).jpg
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1082
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Other Ingredients
Ingredient KindIngredient NameQuantity
Does not containALCOHOL (UNII: 3K9958V90M) 0   in 5 mL
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1082-971 in 1 CARTON06/01/200604/30/2018
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491606/01/200604/30/2018
Labeler - Rugby Laboratories (079246066)

Revised: 12/2017
 
Rugby Laboratories