ASPIRIN 81 MG ENTERIC COATED- aspirin tablet 
Reliable 1 Laboratories LLC

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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Aspirin USP 81mg Enteric Coated Tablet

Drug Facts

Active ingredients (in each tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

Because of its delayed 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 symptons could be an early sign of Reye's syndrome, a rare but serious illness.

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

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

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

feel faint

have bloody or black stools

vomit blood

have stomach pain that does not get better

These could be sings of a serious condition.

If pregnant or brest-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 conplications 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

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?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

NDC 69618-046-10

Enteric Coated

Aspirin USP 81mg (NSAID

Adult Low Strength

PAIN RELIEVER

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

1000 TABLETS

Aspirin 81 mg EC

ASPIRIN 81 MG ENTERIC COATED 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-046
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
IRON (UNII: E1UOL152H7)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize5mm
FlavorImprint Code Heart
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69618-046-02120 in 1 BOTTLE; Type 0: Not a Combination Product05/10/2018
2NDC:69618-046-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34305/10/2018
Labeler - Reliable 1 Laboratories LLC (079718111)
Registrant - Reliable 1 Laboratories LLC (079718111)

Revised: 3/2023
Document Id: f811d81d-eb3b-bf06-e053-6294a90a242b
Set id: 6c6cf852-6821-59e1-e053-2a91aa0a4021
Version: 4
Effective Time: 20230329
 
Reliable 1 Laboratories LLC