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Childrens Ibuprofen by Rugby Laboratories

Dosage form: suspension
Ingredients: IBUPROFEN 100mg in 5mL
Labeler: Rugby Laboratories
NDC Code: 0536-1082

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)

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1082
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSE 2910 (4000 MPA.S) 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1082-971 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
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

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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