ASPIRIN- aspirin tablet, coated 
Kroger Company

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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481R Kroger 41226-481 Aspirin 81 mg Delayed-Release Tablets

DRUG FACTS

Active ingredient (in each tablet)
Aspirin 81 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 taking a prescription drug for

Stop use and ask a doctor if

feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

OTHER INFORMATION

Other information

Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

Questions or comments? 1-800-632-6900

Aspirin-81mg-Kroger-500s - LabelAspirin-120-cartonAspirin-120-labelAspirin-200-cartonAspirin-200-labelAspirin-300-label

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-481
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code HEART
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-481-121 in 1 CARTON06/12/2021
1120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41226-481-201 in 1 CARTON06/12/2021
2200 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:41226-481-31300 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2021
4NDC:41226-481-501 in 1 BOTTLE04/10/2021
4500 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/10/2021
Labeler - Kroger Company (006999528)
Registrant - Time Cap Laboratories, Inc. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Laboratories, Inc.037052099manufacture(41226-481)

Revised: 6/2021
Document Id: c3c22911-74c1-4aeb-e053-2a95a90a95ef
Set id: bbee8ee4-e09d-3ba6-e053-2a95a90af647
Version: 3
Effective Time: 20210602
 
Kroger Company