Label: DIRECT SAFETY ASPIRIN- aspirin tablet, coated
DIRECT SAFETY ASPIRIN- aspirin tablet, film coated

  • NDC Code(s): 61245-616-13, 61245-620-13
  • Packager: Direct Safety
  • 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 August 14, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    temporarily relieves

    ■ headache

    ■ muscle pain

    ■ toothache

    ■ menstrual pain

    ■ pain and fever of colds

    ■ minor pain of arthritis

  • WARNINGS

    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

    Do not use if you are allergic to aspirin or to any other pain reliever/fever reducer

  • ASK 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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    ■ gout

    ■ diabetes

    ■ arthritis

  • STOP USE

    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 more than 10 days

    ■ fever lasts more than 3 days

    ■ if ringing in the ears or loss of hearing occurs

    ■ redness or swelling is present

    ■ new symptoms occur

  • PREGNANCY OR BREAST FEEDING

    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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ drink a full glass of water with each dose

    Adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to
    exceed 12 tablets in 24 hours

    Children under 12 years: consult a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ■ store at room temperature

    ■ avoid excessive heat and humidity

    ■ tamper evident sealed packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    I nactive ingredients

    corn starch, hypromellose*, microcrystalline cellulose*, polyethylene glycol* povidone*, propylene glycol*

    * may contain

  • QUESTIONS

    Questions or comments? 1-800-356-9100

  • PRINCIPAL DISPLAY PANEL

    Direct Safety®

    Aspirin

    Pain Reliever

    Aspirin 325 mg (NSAID)

    Aspirina 325 mg (AINE)

    This Package is for Households without Young Children.

    Este Paquete Es Hogares Sin Ninos Pequenos

    Industrial Pack 500

    (250 Packets of 2 Tablets)

    Conney

  • PRINCIPAL DISPLAY PANEL

    Direct Safety®

    Aspirin

    Pain Reliever

    Aspirin 325 mg (NSAID)

    Aspirina 325 mg (AINE)

    This Package is for Households without Young Children.

    Este Paquete Es Hogares Sin Ninos Pequenos

    Industrial Pack 500

    (250 Packets of 2 Tablets)

    116R

  • INGREDIENTS AND APPEARANCE
    DIRECT SAFETY ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61245-620
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code FR21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61245-620-13250 in 1 BOX02/15/202104/01/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/15/202104/01/2024
    DIRECT SAFETY ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61245-616
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;157;ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61245-616-13250 in 1 BOX02/15/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/15/2021
    Labeler - Direct Safety (023316151)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(61245-616, 61245-620)