St. Joseph Safety Coated Aspirin

Dosage form: tablet, coated
Ingredients: ASPIRIN 81mg
Labeler: Ilex Consumer Products Group, LLC
NDC Code: 76000-180

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.

St. Joseph Safety Coated Aspirin

Active Ingredient (in each tablet)

Aspirin 81mg (NSAID)
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

Temporarily relieves minor aches and pains

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 an 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 other drugs containing prescription or nonprescription NASAIDs (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

 if you have ever had a allergic reaction to any pain reliever or fever reducer.

Ask a doctor before use if:
  • The stomach bleeding warning applies to you
  • You have history of stomach problems such as heartburn
  • You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • You have asthma
  • You are taking a diuretic

Ask a doctor or pharmacist before use if you are taking a prescription drug for:
  • 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
  • Allergic reaction occurs
  • Ringing in the ears or loss of hearing occurs
  • Pain gets worse or lasts more than 10 days
  • New symptoms occur
  • Redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during a delivery.

Keep out of reach of children.

 In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
  • drink a full glass of water with each dose
  • adults and children 12 years and over:  take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours unless directed by a doctor.
  • Children under 12 years of age: Do not use unless directed by a doctor.

Other Information
  • Store at controlled room temperature 15-30 degrees C (59-86 degrees F)
  • Do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

FDandC Red No. 40, FDandC Yellow No. 6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, pregelatinized starch, silica, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, stearic scid, talc, and triethyl citrate.

Questions or comments?

call toll free: 1 855 STJOE81

Product Labeling

Doctor Recommended 81mg Dose

St. Joseph
Safety Coated* Aspirin
Pain Reliever (NSAID)
81mg

Aspirin Regimen
Enteric coated

America's ORiginal
*Coating Helps Protect Against Stomach Upset

Talk to your doctor before staring an aspirin regimen. Aspirin is not right for everyone.

Dist. by: St. Josephs Health Products, LLC
Baltimore, MD 21201

Find out more at stjosephaspirin.com






ST. JOSEPH SAFETY COATED ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76000-180
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
SILICON DIOXIDE 
SODIUM BICARBONATE 
SODIUM LAURYL SULFATE 
TALC 
TRIETHYL CITRATE 
Product Characteristics
Colororange (PEACH) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint CodeSJ
Contains    
Packaging
#Item CodePackage Description
1NDC:76000-180-361 BOTTLE (BOTTLE) in 1 BOX
136 TABLET, COATED (TABLET) in 1 BOTTLE
2NDC:76000-180-121 BOTTLE (BOTTLE) in 1 BOX
2120 TABLET, COATED (TABLET) in 1 BOTTLE
3NDC:76000-180-151 BOTTLE (BOTTLE) in 1 BOX
3150 TABLET, COATED (TABLET) in 1 BOTTLE
4NDC:76000-180-201 BOTTLE (BOTTLE) in 1 BOX
4200 TABLET, COATED (TABLET) in 1 BOTTLE
5NDC:76000-180-301 BOTTLE (BOTTLE) in 1 BOX
5300 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/05/2012
Labeler - Ilex Consumer Products Group, LLC (829056162)

Revised: 03/2012
 
Ilex Consumer Products Group, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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