FDA.reportPublic FDA data

Plus Pharma NSAID Aspirin

Manufacturer
St. Mary's Medical Park Pharmacy | Gemini Pharmaceuticals, Inc. dba Plus Pharma
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:45:45

Label at a glance#

ProductPlus Pharma NSAID Aspirin
Active ingredientASPIRIN
Label structure9 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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 or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

•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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn Starch, Povidone.


Questions?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASPASP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-718-24EA - Each60760-718757679fc-4194-4818-845c-692d7b385a9612018-02-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60760-71860760-718-24
51645-716

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
POVIDONEFZ989GH94EIACT
ASPIRINR16CO5Y76EACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d243bb55-cf55-a1b7-e053-2995a90ac7525f215709-3793-7668-e053-2a91aa0ac3322021-12-03WarningsExact identifier
spl set id: 5f215709-3793-7668-e053-2a91aa0ac332

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.