ASPIRIN - aspirin tablet, delayed release 
Sunrise Pharmaceutical Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Unknown Title

OTC - ACTIVE INGREDIENT

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE

Pain reliever

INDICATIONS AND USAGE

Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

WARNINGS

Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

OTC - DO NOT USE

If you are allergic to aspirin or any other pain reliever/fever reducer.

OTC - ASK A DOCTOR BEFORE USE IF

OTC - ASK A DOCTOR/PHARMACIST BEFORE USE IF YOU ARE

taking a prescription drug for:

OTC - STOP USE AND ASK A DOCTOR IF

OTC - IF PREGNANT OR BREAST FEEDING

ask a health professional before use. It is especially important not to use aspirin 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. 

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

OTHER INFORMATION

INACTIVE INGREDIENT

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil,  polyethylene glycol, propylene glycol, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4a9520e4-figure-01
ASPIRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-073
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorImprint Code SP;03
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11534-073-11120 in 1 BOTTLE
2NDC:11534-073-0557603 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/26/2005
Labeler - Sunrise Pharmaceutical Inc (168522378)

Revised: 8/2013
Document Id: 4a9520e4-2015-4055-a4e2-ec077a8b5f30
Set id: 0acef886-9e67-463f-9901-cb43a6650ecd
Version: 1
Effective Time: 20130801
 
Sunrise Pharmaceutical Inc