Label: ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN- aspirin tablet, chewable
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- NDC Code(s): 69536-281-10, 69536-281-36
- Packager: Foundation Consumer Healthcare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 5, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
- temporarily relieves minor aches and pains
- ask your doctor about other uses for St. Joseph Safety Coated 81 mg Aspirin
- 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 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
- if you are allergic to aspirin or any other pain reliever/fever reducer
- for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
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
- you have asthma
Ask a doctor or pharmacist before use if you are taking a prescription drug for gout, diabetes or arthritis
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- 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 for more than 10 days
- ringing in the ears or loss of hearing occurs
- redness or swelling is present
- new symptoms occur. 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 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.
CloseKeep 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
- adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
- Other information
- Inactive ingredients
corn starch, dextrates hydrated, FD&C yellow #6 aluminum lake, flavor, maltodextrin, sucralose
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box
NDC 69536-281-36
• ADULT ASPIRIN REGIMEN†•
ST. JOSEPH®
LOW DOSE ASPIRIN
CHEWABLE PAIN RELIEVER (NSAID)81 mg
AMERICA'S
ASPIRIN100
YEARSCHEWABLE
Orange
Flavored36
Chewable
TabletsClose
- INGREDIENTS AND APPEARANCE
ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69536-281 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) DEXTRATES (UNII: G263MI44RU) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color ORANGE Score no score Shape ROUND Size 8mm Flavor ORANGE Imprint Code SJC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69536-281-36 1 in 1 BOX 02/17/2017 1 36 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69536-281-10 3 in 1 BOX 02/17/2017 2 108 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 02/17/2017 CloseLabeler - Foundation Consumer Healthcare LLC (079675882)