Label: UNISHIELD ASPIRIN- aspirin tablet, coated
UNISHIELD ASPIRIN- aspirin tablet, film coated

  • NDC Code(s): 49314-1163-3, 49314-1173-3
  • Packager: Unishield
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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

    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

    Inactive ingredients

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

    * may contain

  • QUESTIONS

    Questions or comments? 800-480-5855

  • Unishield Aspirin Label

    Unishield

    Aspirin 325 mg

    Pain Reliever/Fever Reducer (NSAID)

    100 Tablets/2Tablets Per Packet

    Pull To Open

    This Package is for Households Without Young Children.

    • Relieves headaches,muscule pain and minor arthritis pain

    Compare active ingredient to:

    Genuine Bayerl®

    Registered Trademark of Bayer Corp.

    Tamper Evident Unit Dose Packets

    116R

  • Unishield Aspirin Label

    Aspirin 325 mg

    Pain Reliever/Fever Reducer (NSAID)

    100 Tablets/2Tablets Per Packet

    Pull To Open

    This Package is for Households Without Young Children.

    • Relieves headaches,muscule pain and minor arthritis pain

    Compare active ingredient to:

    Genuine Bayerl®

    Registered Trademark of Bayer Corp.

    Tamper Evident Unit Dose Packets

    Aspirin

  • INGREDIENTS AND APPEARANCE
    UNISHIELD ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-1173
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code FR21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-1173-350 in 1 BOX03/01/202104/01/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/01/202104/01/2024
    UNISHIELD ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-1163
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;157;ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-1163-350 in 1 BOX03/01/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/01/2021
    Labeler - Unishield (790677053)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(49314-1163, 49314-1173)