Plus Pharma
FDA Label NDC 64725-0716

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tya Pharmaceuticals for the product Plus Pharma (NDC 64725-0716). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

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:



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



    • 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
  • haveĀ  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

Otc - Pregnancy 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. 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

  • Drink a full glass of water with each dose
  • Do not take more than directed
  • 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 Adults and children 12 years and older:
  • ask a doctor Children under 12:

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.

* Please review the disclaimer below.