ADULT LOW DOSE- aspirin 81 mg tablet, delayed release 
Safrel Pharmaceuticals, 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 81 mg Enteric Coated Tablets

Drug Facts

Active Ingredients (in each tablet)                          Purpose

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

*nonsteroidal anti-inflammatory drug

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

Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions or comments?

Call toll free 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.safrel.com

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 Enteric Coated Tablets, 81 mg

NDC 71309-003-05

500 Count

NDC 71309-003-10

1000 ct

ADULT LOW DOSE 
aspirin 81 mg tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71309-003-2525 in 1 BOX06/05/2017
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:71309-003-5050 in 1 BOX06/05/2017
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:71309-003-022 in 1 POUCH06/05/2017
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:71309-003-05500 in 1 BOTTLE01/09/2021
4NDC:71309-003-011000 in 1 BOTTLE
4NDC:71309-003-65365 in 1 BOTTLE
4NDC:71309-003-3030 in 1 BOTTLE
41 in 1 CARTON; Type 0: Not a Combination Product
5NDC:71309-003-601 in 1 CARTON06/05/2017
560 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:71309-003-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34302/09/2016
Labeler - Safrel Pharmaceuticals, LLC. (080566287)

Revised: 3/2023
Document Id: f7f18cee-564d-13c4-e053-6294a90ad4a8
Set id: 87401db3-7162-b48b-e053-2a95a90ac98f
Version: 6
Effective Time: 20230328
 
Safrel Pharmaceuticals, LLC.