Label: DIRECT SAFETY ASPIRIN- aspirin tablet, film coated

  • NDC Code(s): 61245-116-13
  • Packager: Conney Safety Products, LLC
  • 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 March 6, 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 (NSAID*) 325 mg

    *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
    • skin reddening
    • facial swelling
    • rash
    • asthma (wheezing)
    • blisters
    • 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
    • right before or after heart surgery
    • 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
    • you have difficulty swallowing
    • 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:             Take 1 or 2 tablets with water every 4 hours as needed. Do not
    (12 years and older)             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 59º-86ºF (15º-30ºC)
    • 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?

    1-800-356-9100

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  • PRINCIPAL DISPLAY PANEL

    116R Direct Safety Aspirin Label

    Direct Safety®

    Aspirin

    Pain Reliever

    Aspirin 325 mg. (NSAID)

    Aspirina 325 mg. (AINE)

    Lightly Coated

    Industrial Pack 500

    (250 Packets of 2 Tablets)

    116R Direct Safety Aspirin Label
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  • INGREDIENTS AND APPEARANCE
    DIRECT SAFETY ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61245-116
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 10mm
    Flavor Imprint Code TCL;011
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61245-116-13 250 in 1 BOX, UNIT-DOSE 05/03/2013
    1 2 in 1 PACKET; 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 05/03/2013
    Labeler - Conney Safety Products, LLC (023316151)
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