PAIN RELIEVER- aspirin 81 mg tablet, delayed release 
HealthLife Of USA

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Pain Reliever - Aspirin Delayed Release Tablets, 81 mg

Drug Facts

Active Ingredients (in each caplet)                    Purpose

Aspirin 81 mg (NSAID)* ........................................ Pain reliever

*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:

  • hives
  • shock
  • facial swelling
  • asthma (wheezing)

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

  • you have asthma
  • 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

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • under a doctor's care for any serious condition
  • taking any other drug

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • an allergic reaction occurs.

   Seek medical help right away.

  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling present in the painful area
  • new symptoms occur

These could be sign 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

May Contains:

Starch, Povidone, Microcrystalline cellulose, Crosscarmellose Sodium,  Stearic Acid, Colloidal Sillicon Dioxide, Methacrylic acid copolymer and ethyl acrylate co-polymer, Triethyl Citrate, Talc, Fumed Silica, Titanium Dioxide, D&C Yellow #10, FD&C Yellow#6.

Questions or comments?

Call 1-844-832-1138

9AM – 5PM EST Monday - Friday  

PRINCIPAL DISPLAY PANEL

See New Warnings Information & Directions

Compare to Bayer ®Low Dose Aspirin active ingredients

This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer ®Low Dose Aspirin.

Aspirin Delayed Release Tablets, 81 mg

Principal Display Panel

PAIN RELIEVER 
aspirin 81 mg tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69517-104-2525 in 1 BOX06/05/201706/05/2017
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:69517-104-5050 in 1 BOX06/05/201706/05/2017
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:69517-104-022 in 1 POUCH06/05/201706/05/2017
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:69517-104-011000 in 1 BOTTLE06/05/2017
4NDC:69517-104-65365 in 1 BOTTLE
4NDC:69517-104-3030 in 1 BOTTLE
41 in 1 CARTON; Type 0: Not a Combination Product
5NDC:69517-104-601 in 1 CARTON06/05/2017
560 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:69517-104-03300 in 1 BOTTLE; Type 0: Not a Combination Product11/29/2023
7NDC:69517-104-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/29/2023
8NDC:69517-104-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01302/09/2016
Labeler - HealthLife Of USA (079656178)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceutical Ltd.915664486manufacture(69517-104)
Establishment
NameAddressID/FEIBusiness Operations
Health Pharma USA LLC080804485manufacture(69517-104)

Revised: 11/2023
Document Id: 0b58610e-943c-7655-e063-6394a90af56f
Set id: f0ce670a-179a-462c-ad4f-02129c456ffb
Version: 11
Effective Time: 20231129
 
HealthLife Of USA