ASPIRIN 81- aspirin tablet 
Rising Pharma Holdings, Inc.

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Aspirin 81 mg

DRUG FACTS

Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)#
#nonsteroidal anti-inflammatory drug

Purpose
Pain reliever

Uses

• temporarily relieves minor aches and pains

• ask your doctor about other uses for enteric coated 81 mg Aspirin.

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:

•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 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

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are taking a prescription drug for gout, diabetes or 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 ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better

  • pain gets worse or lasts more than 10 days
  • ringing in the ears or a loss of hearing occurs
  • redness or swelling is present
  • new symptoms occur. These could be signs of a serious condition.

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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, crosscarmellose sodium, D&C yellow#10, FD&C yellow#6, methacrylic acid copolymer, microcrystalline cellulose, silicon dioxide, stearic acid, talcum, titanium dioxide, triethyl citrate

Questions or comments? Call 1-844-474-7464

Rising Health

Aspirin 81 mg

NDC 57237-302-10

1000 Tabletsaspirin-label

ASPIRIN 81 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code I1;Plain
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-302-12120 in 1 BOTTLE; Type 0: Not a Combination Product10/25/2022
2NDC:57237-302-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM013.5010/25/2022
Labeler - Rising Pharma Holdings, Inc. (116880195)
Establishment
NameAddressID/FEIBusiness Operations
Invahealth Inc.116840615manufacture(57237-302) , analysis(57237-302) , label(57237-302) , pack(57237-302)

Revised: 10/2024
Document Id: ffa0c51f-1493-4897-99cf-8ae6ab2a6f05
Set id: bfc4fd55-45db-41f4-b878-a6b7155f0849
Version: 2
Effective Time: 20241017
 
Rising Pharma Holdings, Inc.