Label: ASPIRIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 76000-231-12, 76000-231-15, 76000-231-20, 76000-231-30, view more76000-231-36, 76000-231-65 - Packager: Bedrock Brands, LLC (ST. JOSEPH)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 1, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
- shock
- asthma (wheezing)
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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
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 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
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away.
- new symptoms occur
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- ringing in the ears or a loss of hearing occurs
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
• ADULT ASPIRIN REGIMEN‡
LOW DOSE ASPIRIN
SAFETY COATED†
PAIN RELIEVER (NSAID)
81 mg
DOCTOR RECOMMENDED
Enteric Coated
Micro** Tablets
Dist. by: St. Josephs Health Products, LLC
Irvington, NY 10533
Find out more at stjosephaspirin.com
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Gluten Free
†Coating Helps Protect Against Stomach Upset
‡Talk to your doctor before starting an aspirin regimen. Aspirin is not right for everyone.
**Now in a new, smaller, easier to swallow "micro tablet"
- Product Label
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76000-231 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 FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color WHITE (PEACH) Score no score Shape ROUND Size 7mm Flavor Imprint Code SJ Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76000-231-15 1 in 1 BOX 1 150 in 1 BOTTLE, PLASTIC 2 NDC:76000-231-36 1 in 1 BOX 2 36 in 1 BOTTLE, PLASTIC 3 NDC:76000-231-12 1 in 1 BOX 3 120 in 1 BOTTLE, PLASTIC 4 NDC:76000-231-20 1 in 1 BOX 4 200 in 1 BOTTLE, PLASTIC 5 NDC:76000-231-30 1 in 1 BOX 5 300 in 1 BOTTLE, PLASTIC 6 NDC:76000-231-65 1 in 1 BOX 6 365 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 05/30/2014 Labeler - Bedrock Brands, LLC (ST. JOSEPH) (829056162)
