REGULAR STRENGTH ENTERIC COATED ASPIRIN- aspirin tablet, coated 
Geri-Care Pharmaceutical Corp

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gc 921

Active ingredient (in each tablet)

Aspirin 325 mg(NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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:

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in
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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

black iron oxide, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, polydextrose,
polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, silicon dioxide, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.

Questions or comments?

1-800-540-3765

package label

1

REGULAR STRENGTH ENTERIC COATED ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-921
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 44;227
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-921-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2012
2NDC:57896-921-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2012
3NDC:57896-921-25250 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201208/01/2022
4NDC:57896-921-50500 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2012
5NDC:57896-921-20200 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/01/2000
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 10/2023
Document Id: 08a3b4e3-69e1-e206-e063-6294a90af268
Set id: c321208c-f192-42c5-9454-e0df5d02d685
Version: 7
Effective Time: 20231026
 
Geri-Care Pharmaceutical Corp