Label: ASPIRIN- aspirin tablet, delayed release 

  • Label RSS
  • NDC Code(s): 57344-146-01, 57344-146-02, 57344-146-03, 57344-146-04, view more
    57344-146-05, 57344-146-06
  • Packager: AAA Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID1)


    1
    nonsteroidal anti-inflammatory drug
    Close
  • Purpose

    Pain reliever

    Close
  • Uses

    • temporarily relieves minor aches and pains
    Close
  • 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 have ever had an allergic reaction to any other pain reliever/fever reducer

    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
    • 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
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs

    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.

    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).

    Close
  • 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; do not exceed 48 tablets in 24 hours
    • children under 12 years: do not use unless directed by a doctor
    Close
  • Other information

    • store between 20°-25°C (68°-77°F) in a dry place
    • retain carton for complete product information
    Close
  • Inactive ingredients

    acetylated monoglycerides, anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, hypromellose phthalate, iron oxide yellow, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polyethylene glycol, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

    Close
  • PRINCIPAL DISPLAY PANEL - 180 Tablet Bottle Carton

    RESTORE u

    NDC 57344-146-01

    COMPARE TO THE ACTIVE
    INGREDIENT IN ST JOSEPH®
    SAFETY COATED ASPIRIN

    ADULT
    LOW DOSE

    Safety
    Coated

    Aspirin
    Pain Reliever
    (NSAID)

    81mg

    180 ENTERIC COATED TABLETS - 81 mg each

    PRINCIPAL DISPLAY PANEL - 180 Tablet Bottle Carton
    Close
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57344-146
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    DIACETYLATED MONOGLYCERIDES  
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
    FERRIC OXIDE YELLOW  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    DIMETHICONE  
    SODIUM HYDROXIDE  
    SODIUM LAURYL SULFATE  
    TALC  
    TITANIUM DIOXIDE  
    TRIETHYL CITRATE  
    Product Characteristics
    Color ORANGE (PEACH) Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code heart
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-146-01 1 in 1 CARTON
    1 180 in 1 BOTTLE, PLASTIC
    2 NDC:57344-146-02 1 in 1 CARTON
    2 300 in 1 BOTTLE, PLASTIC
    3 NDC:57344-146-03 1 in 1 CARTON
    3 100 in 1 BOTTLE, PLASTIC
    4 NDC:57344-146-04 2 in 1 CARTON
    4 180 in 1 BOTTLE, PLASTIC
    5 NDC:57344-146-05 300 in 1 BOTTLE, PLASTIC
    6 NDC:57344-146-06 500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 12/15/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
    Close