LOW DOSE ASPIRIN- aspirin tablet, delayed release 
Spirit Pharmaceuticals LLC

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ASPIRIN 81MG ADULT LOW DOSE

Drug Facts

Active Ingredient (in each tablet)

Aspirin 81 mg (NSAID)nonsterodial 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, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reyes syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, facial swelling, asthma(wheezing), shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or olderHave had stomach ulcers or bleeding problemsTake a blood thinning (Anticogulant) or steroid drugTake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day using this product

Do not Use

if you are allergic to aspirin or any other pain reliever/fever reducerif you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if stomach bleeding warning applies to you
you ahistory of stomach problems such as heart burnyou have blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic, you have asthama

Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking a prescription drug for:Gout, Diabetes, Arthritis

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away.You experience any of the following signs of stomach bleeding: feel faint, vomt blood, have bloody or black stools, have stomach pain that does not get better, pain get worse or lasts more than 10 days, fever gets worse or lasts more than 3 daysredness or swelling is present, new symptons occurringing in the ears or a loss of hearing occurs.

If pregnant or breast-feeding ask ahealth professional before use. it is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it my 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 poison control center right away.

Directions

drink a full glass of water with each dose

adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

Other information

Store at room temparature. Avoid excessive heat above 40°C (104 °F) 

Inactive ingredients

acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow # 10, Lactose, microcrystalline cellulose, polysorbate 80,

sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron 

Questions or Comments

1-888-333-9792

Principal Display

Carton
LOW DOSE ASPIRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-5029
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
METHACRYLIC ACID (UNII: 1CS02G8656)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 81
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-5029-41 in 1 CARTON12/14/2023
140 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/14/2023
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0c7c4492-ef51-0614-e063-6294a90a78ba
Set id: 199f0043-17f6-4620-9658-b4b07fb50be7
Version: 1
Effective Time: 20231214
 
Spirit Pharmaceuticals LLC