Your browser does not support JavaScript! CEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]
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CEDAPRIN (ibuprofen) tablet
[North Safety Products LLC ]


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

temporarily relieves minor aches and pains due to:
headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis
temporarily 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 you
are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed
Do not use if you have 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 you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma you are taking a diuretic
Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 you experience any of the following signs of stomach bleeding:
feel faint vomit blood have bloody or black stools have stomach pain that does not get better
pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Inactive Ingredients: Corn Starch, DC yellow 10, FDC Blue 1, Microcrystalline Cellulose, Povidone, stearic acid

Pain Reliever, Fever Reducer

Active Ingredient (in each tablet): Ibuprofen 200 mg

Directions:
do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

MM1Cedaprin 500ct cartonEnter section text here

CEDAPRIN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0498-7500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
SILICON DIOXIDE 
POLYETHYLENE GLYCOL 
CELLULOSE, MICROCRYSTALLINE 
FD&C RED NO. 40 
FD&C BLUE NO. 2 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MALTODEXTRIN 
POLYDEXTROSE 
TITANIUM DIOXIDE 
Product Characteristics
Colorbrown (CHOCOLATE BROWN) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU;200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-7500-50250 in 1 BOX
1NDC:0498-7500-25125 in 1 BOX
1NDC:0498-7500-1050 in 1 BOX
1NDC:0498-7500-012 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912903/07/2012
Labeler - North Safety Products LLC (059980441)
Registrant - North Safety Products LLC (059980441)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc. 151051757manufacture
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004repack

Revised: 3/2012
 
North Safety Products LLC

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