ASPIRIN ENTERIC COATED- aspirin 81 mg tablet 
Allegiant Health

----------

Bio Formula Aspirin 81mg

Active ingredient

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pain or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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:

Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding.The chance is higher if you:

Do not use

if you are allergic to aspirin or 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
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • 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
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • You may report serious side effects to 1-888-952-0050

Pregnancy/Breastfeeding

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 specifically 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

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

anhydrous lactose, carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, silicon dioxide, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Principal Display Panel

Bio Formula

ASPIRIN

(NSAID*)

81mg SAFETY COATED

ENTERIC COATED

LOW STRENGTH ASPIRIN REGIMEN

DELAYED RELEASE ASPIRIN

Bio Formula Aspirin 81mg Carton 100ct

Bio Formula Aspirin 81mg Carton 100ct

Bio Formula Aspirin 81mg Label 100ct

Bio Formula Aspirin 81mg Label 100ct

Bio Formula Aspirin 81mg Label 300ct

Bio Formula Aspirin 81mg Label 300ct

ASPIRIN  ENTERIC COATED
aspirin 81 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-318
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-318-011 in 1 CARTON12/18/2014
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69168-318-03300 in 1 BOTTLE; Type 0: Not a Combination Product12/18/2014
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/18/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)

Revised: 11/2018
Document Id: 2899105f-ce56-4f8f-8966-0f18aed41d75
Set id: 5910a882-eb40-440f-8a30-c21fbce9050e
Version: 6
Effective Time: 20181107
 
Allegiant Health