Regular strength enteric coated aspirin tablet, coated

Active ingredient (in each tablet)

Aspirin 325 mg(NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin

Directions

  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush
  • do not exceed recommended dose
  • adultsand children 12 years and older: take 1-2 tablets every 4 hours, asneeded, not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at room temperature 15C - 30C (59F - 86F)
  • for institutional use only

Inactive ingredients

cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, shellac wax, silica, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose phthalate, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.

Ingredients and appearance - Product information

Regular strength enteric coated aspirin tablet, coated- Aspirin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 66267-026
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Aspirin ( UNII: R16CO5Y76E)( Aspirin - UNII: R16CO5Y76E ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
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

Score 1 Shape ROUND
Imprint Code 44;227 Size 9 mm
Color orange

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 66267-026-30 30 in 1 BOTTLE 2016/09/28
2 NDC: 66267-026-60 60 in 1 BOTTLE 2016/09/28
3 NDC: 66267-026-90 90 in 1 BOTTLE 2016/09/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part343 USA 2016/09/28

Labeler - NuCare Pharmaceuticals, Inc.( 010632300)

Establishment

Name ID/FEI Business Operations
NuCare Pharmaceuticals, Inc. 010632300 repack( 66267-026)