ST. JOSEPH SAFETY COATED ASPIRIN- aspirin tablet, coated 
Bedrock Brands, LLC (ST. JOSEPH)

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 Aspirin


St. Joseph Aspirin
ST. JOSEPH SAFETY COATED ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76000-180
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorORANGE (PEACH) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code SJ
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76000-180-361 in 1 BOX
136 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:76000-180-121 in 1 BOX
2120 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:76000-180-151 in 1 BOX
3150 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:76000-180-201 in 1 BOX
4200 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:76000-180-301 in 1 BOX
5300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/05/201212/31/2016
Labeler - Bedrock Brands, LLC (ST. JOSEPH) (829056162)

Revised: 3/2016
 
Bedrock Brands, LLC (ST. JOSEPH)