ASPIRIN 81 MG ENTERIC COATED- aspirin tablet 
Marlex Pharmaceuticals Inc

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 USP 81mg Enteric Coated Tablet

ASPIRIN 81 MG ENTERIC COATED- aspirin tablet Reliable 1 Laboratories 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 USP 81mg Enteric Coated Tablet

Drug Facts

Active ingredients (in each tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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 symptons could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which any include:

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

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
  • you have not been dirinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

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

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
  • have bloody or black stools vomit blood
  • 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 a loss of hearing occurs

These could be sings of a serious condition.

If pregnant or brest-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 conplications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

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

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday – Friday

PRINCIPAL DISPLAY PANEL

NDC 10135-0173-62
Aspirin

81mg
Low Strength 81 mg ASPIRIN

(NSAID)
 
Enteric Coated

1 ¼ gr. (81 mg) each Analgesic

PRINCIPAL DISPLAY PANEL
NDC 10135-0173-62
Aspirin
81mg 
Low Strength 81 mg ASPIRIN
(NSAID) 
Enteric Coated
1 ¼ gr. (81 mg) each Analgesic

PRINCIPAL DISPLAY PANEL
NDC 10135-0173-62
Aspirin
81mg 
Low Strength 81 mg ASPIRIN
(NSAID) 
Enteric Coated
1 ¼ gr. (81 mg) each Analgesic

ASPIRIN 81 MG ENTERIC COATED 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-173
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
IRON (UNII: E1UOL152H7)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize5mm
FlavorImprint Code Heart
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-173-62120 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/01/2018
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 10/2019
Document Id: 555052ca-376e-4277-9c5c-4c76974f9447
Set id: 660b80f4-58a6-4d7a-b8a8-f382f940f6da
Version: 2
Effective Time: 20191018
 
Marlex Pharmaceuticals Inc