Label: ASPIRIN- aspirin tablet

  • NDC Code(s): 48083-654-27, 48083-654-30, 48083-654-33, 48083-654-36, view more
    48083-654-39, 48083-654-41, 48083-654-66
  • Packager: Certified Safety Manufacturing
  • 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 December 15, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Aspirin (NSAID1) 325 mg


    1
    nonsteroidal anti-inflammatory drug
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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    Temporarily relieves minor aches and pains associated with

    • headache
    • minor arthritis pain
    • common cold
    • menstrual cramps
    • muscular aches
    • backache
    • toothache

    Temporarily reduces fever.

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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
    • asthma (wheezing)
    • shock

    If an allergic reaction occurs, stop use and seek medical help right away.

    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 alcohol 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
    • if you are taking prescription drugs for gout, diabetes or arthritis

    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

    • under a doctor's care for any serious condition
    • taking any other drug

    When using this product

    • take with food or milk if stomach upset occurs

    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
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • if ringing in the ears or loss of hearing occurs
    • redness or swelling is present in the painful area
    • any new symptoms appear

    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.

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  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)
    • drink a full glass of water with each dose
    Adults and children:
    (12 years and older)
    Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.
    Children under 12 years: Do not give to children under 12 years of age.
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  • Other information

    • read all product information before using
    • store at room temperature 59°-86°F (15°-30°C)
    • avoid excessive heat and humidity
    • tamper evident sealed packets
    • do not use any opened or torn packets
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  • Inactive ingredients

    corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

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  • Questions or comments?

    1-800-xxx-xxxx

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  • PRINCIPAL DISPLAY PANEL - 25 Pouch Box

    Tamper evident
    packaging:
    Do not use if
    open or torn.

    This package for
    households
    without children

    See New Warnings
    Information

    Compare to Bayer®

    CERTI-ASPIRIN™

    325 mg Aspirin (NSAID)*

    • Pain Reliever
    • Fever Reducer
    PRINCIPAL DISPLAY PANEL - 25 Pouch Box
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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:48083-654
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Mineral Oil (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code TCL;011
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48083-654-66 24 in 1 BOX 12/29/2017
    1 2 in 1 POUCH; Type 0: Not a Combination Product
    2 NDC:48083-654-27 25 in 1 BOX 12/29/2017
    2 2 in 1 POUCH; Type 0: Not a Combination Product
    3 NDC:48083-654-30 50 in 1 BOX 12/29/2017
    3 2 in 1 POUCH; Type 0: Not a Combination Product
    4 NDC:48083-654-33 125 in 1 BOX 12/29/2017
    4 2 in 1 POUCH; Type 0: Not a Combination Product
    5 NDC:48083-654-36 250 in 1 BOX 12/29/2017
    5 2 in 1 POUCH; Type 0: Not a Combination Product
    6 NDC:48083-654-39 500 in 1 BOX 12/29/2017
    6 2 in 1 POUCH; Type 0: Not a Combination Product
    7 NDC:48083-654-41 1000 in 1 BOX 12/29/2017
    7 2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 12/29/2017
    Labeler - Certified Safety Manufacturing (788460483)
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