PLUS PHARMA NSAID ASPIRIN- aspirin tablet 
Gemini Pharmaceuticals, Inc. dba Plus Pharma

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 325 mg Tablets

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

for temporary relief of

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • minor aches and pains
  • temporarily reduces fever

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 a nonsteroidal anti-inflammatory drug (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

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

If pregnant or breast-feeding, 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.

Keep out of reach of children.

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

Directions

  • Drink a full glass of water with each dose
  • Do not take more than directed
  • Adults and children 12 years and older: take 1 to 2 tablets every 4 hours, or 3 tablets every 6 hours as needed. Do not take more than 12 tablets in 24 hours
    Children under 12: ask a doctor

Other information

  • Do not use if imprinted safety seal under cap is broken or missing.
  • Store at room temperature

Inactive ingredients

Corn Starch, Povidone.


Questions?

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

Principal Display Panel

PlusPHARMA

ASPIRIN 325 mg

NSAID

SAFE, FAST PAIN RELIEF FROM:

  • HEADACHES
  • COMMON ACHES AND PAINS

PAIN RELIEVER/FEVER REDUCER

*Compare to the Active Ingredient in Genuine Bayer® Aspirin

*Plus Pharma is not affiliated with the owner of the registered trademark Bayer®

100 TABLETS 325 mg each

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PlusPHARMA

ASPIRIN 325 mg

NSAID

SAFE, FAST PAIN RELIEF FROM:

  • HEADACHES
  • COMMON ACHES AND PAINS

PAIN RELIEVER/FEVER REDUCER

*Compare to the Active Ingredient in Genuine Bayer® Aspirin

*Plus Pharma is not affiliated with the owner of the registered trademark Bayer®

1000 TABLETS 325 mg each


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PLUS PHARMA NSAID ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-716
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (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:51645-716-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/200601/31/2019
2NDC:51645-716-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/200601/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/27/200601/31/2019
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)

Revised: 12/2019
 
Gemini Pharmaceuticals, Inc. dba Plus Pharma