Your browser does not support JavaScript! SHOPRITE IBUPROFEN IB (IBUPROFEN) TABLET, CHEWABLE [WAKEFERN FOOD CORPORATION]
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SHOPRITE IBUPROFEN IB (ibuprofen) tablet, chewable
[Wakefern Food Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient (in each tablet)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

reduces fever
relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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

mouth or throat burning may occur; give with food or water
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
find the right dose on chart below. 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)

Tablets

under 24

under 2

ask a doctor

24-35

2-3

1

36-47

4-5

1 ½

48-59

6-8

2

60-71

9-10

2 ½

72-95

11

3

Other information

phenylketonurics: contains phenylalanine 6 mg per tablet
do not use if printed seal under cap is broken or missing
store at 20-25°C (68-77°F)
see end panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions or comments?

1-800-SHOPRITE

Principal Display Panel

Compare to: Active Ingredient in Motrin® Junior Strength

SEE NEW WARNINGS INFORMATION

Junior Strength

AGES 2-11

IBUPROFEN IB

Ibuprofen Tablets, 100mg

Pain Reliever – Fever Reducer (NSAID)

Lasts up to 8 hours

24 orange-flavored chewable tablets

ShopRite Ibuprofen IB.jpg
ShopRite Ibuprofen IB.jpg
SHOPRITE IBUPROFEN IB 
ibuprofen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41190-461
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MANNITOL 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
SOYBEAN OIL 
SUCCINIC ACID 
ACESULFAME POTASSIUM 
Product Characteristics
ColorORANGEScore2 pieces
ShapeROUNDSize13mm
FlavorORANGEImprint Code L461
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41190-461-621 in 1 CARTON
124 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07635907/02/2013
Labeler - Wakefern Food Corporation (069722418)

Revised: 9/2013
 
Wakefern Food Corporation

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