CEDAPRIN- ibuprofen tablet 
Honeywell Safety Products USA, Inc

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0498-7500, 0498-7501 & 0498-7502: Cedaprin

Active Ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)

*(nonsteroidal anti-inflammatory drug)

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:


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

Heart attack and stroke warning:

Do not use

  • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • you have problems or serious side effectsfrom taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
  • you are taking a diuretic

Ask a doctor or a pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease the benefit of aspirin
  • under a doctors care for any serious condition
  • taking any other drug

When using this product,

take with food or milk if stomach upset occurs

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

  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in oe part or side of body
  • slurred speech
  • leg swelling

  • 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 reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other Information

Inactive ingredients

hypromellose, lactose monohydrate, opadry II 31K, povidone K-30, ferric oxide red, silicon dioxide, starch, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-800-430-5490

Cedaprin Old

MM1 Cedaprin 500ct carton Enter section text here

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CEDAPRIN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-7502
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
TRIACETIN (UNII: XHX3C3X673)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-7502-10100 in 1 BOX01/02/2017
1NDC:0498-7502-012 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0498-7502-25250 in 1 BOX07/23/2019
2NDC:0498-7502-012 in 1 PACKET; Type 0: Not a Combination Product
3NDC:0498-7502-50500 in 1 BOX01/02/2017
3NDC:0498-7502-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912901/02/2017
CEDAPRIN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-7500
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
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 BOX03/07/201201/01/2017
1NDC:0498-7500-25125 in 1 BOX
1NDC:0498-7500-1050 in 1 BOX
1NDC:0498-7500-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912903/07/201201/01/2017
CEDAPRIN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-7501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorbrown (CHOCOLATE BROWN) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU;200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-7501-10100 in 1 BOX01/02/2017
1NDC:0498-7501-012 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0498-7501-25250 in 1 BOX01/02/2017
2NDC:0498-7501-012 in 1 PACKET; Type 0: Not a Combination Product
3NDC:0498-7501-50500 in 1 BOX01/02/2017
3NDC:0498-7501-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912901/02/2017
Labeler - Honeywell Safety Products USA, Inc (118768815)
Registrant - Honeywell Safety Products USA, Inc (118768815)

Revised: 1/2024
Document Id: 0f50b9b5-b96d-3e0b-e063-6394a90a2aec
Set id: 82392922-edec-4a98-a0d9-9a5fe33fd39a
Version: 15
Effective Time: 20240119
 
Honeywell Safety Products USA, Inc