Good Sense Ibuprofen Childrens (Ibuprofen) Suspension [Rebel Distributors Corp] -

GOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [REBEL DISTRIBUTORS CORP]
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NDC	42254-117-12
Set ID	cf785971-902f-4423-866e-6edf44706679
Category	HUMAN OTC DRUG LABEL
Packager	Rebel Distributors Corp
Generic Name
Product Class
Product Number
Application Number	ANDA074937

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Active ingredient (in each 5 mL = 1 teaspoonful)

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 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
- the 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

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
wash dosage cup after each use

Dosing Chart
Weight (lbs)	Age(yrs)	Dose (teaspoonful 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	1 ½ tsp or 7.5 mL
48-59 lbs	6-8 years	2 tsp or 10 mL
60-71 lbs	9-10 years	2 ½ 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 at 20-25°C (68-77°F)
- see bottom panel for lot number and expiration date
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
Questions or comments?

1-800-719-9260
Principal Display Panel

For Ages 2-11

See New Warnings Information

Children's Ibuprofen Oral Suspension

100 mg per 5 mL (Teaspoonful)

Pain Reliever

Fever Reducer (NSAID)

Lasts Up To 8 Hours

Alcohol Free

Berry Flavor

Compare to active ingredient of Children's Motrin®

INGREDIENTS AND APPEARANCE

GOOD SENSE IBUPROFEN CHILDRENS
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42254-117(NDC:0113-0897)
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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)

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

#	Item Code	Package Description
Packaging
1	NDC:42254-117-12	1 in 1 CARTON
1		120 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074937	01/07/1999

Labeler - Rebel Distributors Corp (118802834)

Name	Address	ID/FEI	Business Operations
Establishment
Rebel Distributors Corp		118802834	RELABEL, REPACK

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Medic

GOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [REBEL DISTRIBUTORS CORP]

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if the child is

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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