PLUS PHARMA  NSAID 325 MG- aspirin tablet 
TYA Pharmaceuticals

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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Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

for temporary relief of



Warnings

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. Reye's syndrome:

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



This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning:



Do not use

with any other product containing Aspirin or if you have ever had an allergic reaction to aspirin or other pain relievers/fever reducers.


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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for



  • anticoagulation (blood thinning)
  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

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

, ask a health professional before use. It is especially important not to use Aspirin during 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. If pregnant or breast-feeding

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

Corn Starch, Povidone.


Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

PLUS PHARMA NSAID 325 MG (ASPIRIN) TABLET

Label Image
PLUS PHARMA   NSAID 325 MG
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-0716(NDC:51645-716)
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)  
POVIDONES (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (bi-convex tablet) Size10mm
FlavorImprint Code Aspirin;GPI
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64725-0716-1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/29/2014
Labeler - TYA Pharmaceuticals (938389038)
Registrant - TYA Pharmaceuticals (938389038)
Establishment
NameAddressID/FEIBusiness Operations
TYA Pharmaceuticals938389038RELABEL(64725-0716) , REPACK(64725-0716)

Revised: 9/2014
Document Id: b2310339-e7c0-4deb-9899-ba0a692891bb
Set id: 42313186-9625-4c90-937b-8e9b9f73047a
Version: 2
Effective Time: 20140929
 
TYA Pharmaceuticals