ADULT LOW DOSE PAIN RELIEVER- aspirin tablet, delayed release 
TWIN MED LLC

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Adult Low Dose Aspirin Delayed Release Tablets, 81 mg

Drug Facts

Active ingredients (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:

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

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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

Starch, Povidone, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and Ethyl acrylate Co-polymer, Triethyl Citrate, Talc, Fumed Silica, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6.

Questions or comments?

call toll-free 1-844-912-4012

Distributed by:

Twin Med LLC

Santa Fe Springs,

CA 90670

www.procureproducts.com

Made in the USA

PRINCIPAL DISPLAY PANEL

NDC 55681-403-03

*Compare to active ingredients in Bayer ®Aspirin Low Dose 81 mg

Adult Low Dose Pain Reliever Aspirin Delayed Release Tablets, 81 mg

Pain Reliever (NSAID)

Enteric Coated

300 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Bayer ®.

Aspirin

ADULT LOW DOSE PAIN RELIEVER 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-403
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 A1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55681-403-03300 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/01/2024
Labeler - TWIN MED LLC (009579330)

Revised: 8/2024
Document Id: 1f764d21-1aa8-0553-e063-6294a90afdbe
Set id: a395acf4-f487-4c98-8c44-ca2aaaf72deb
Version: 1
Effective Time: 20240801
 
TWIN MED LLC