Label: UNISHIELD EXTRA STRENGTH NON-ASPIRIN- acetaminophen tablet
UNISHIELD EXTRA STRENGTH NON-ASPIRIN- acetaminophen tablet, film coated

  • NDC Code(s): 49314-1753-3, 49314-1763-3, 49314-1773-3
  • Packager: Unishield
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 31, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 500 mg.

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains due to:

    ■ headache

    ■ muscular aches

    ■ backache

    ■ minor pain of arthritis

    ■ the common cold

    ■ toothache

    ■ premenstrual and menstrual cramps

    temporarily reduces fever

  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    ■ more than 4,000 mg in 24 hours, which is the maximum daily amount

    ■ with other drugs containing acetaminophen

    ■ 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    ■ skin reddening

    ■ blisters

    ■ rash

    If a skin reaction occurs, stop use and seek medical help right away.

  • DO NOT USE

    Do not use

    ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a
    drug contains acetaminophen, ask a doctor or pharmacist.

    ■ if you are allergic to acetaminophen or any of the inactive ingredients in this product

  • ASK DOCTOR

    Ask a doctor before use if you have

    ■ liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if

    ■ you are taking the blood thinning drug warfarin

  • STOP USE

    Stop using and ask a doctor if

    ■ pain gets worse or lasts more than for more than 10 days

    ■ fever gets worse or lasts more than 3 days

    ■ new symptoms occur

    ■ redness or swelling is present

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Overdose Warning:

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    do not use more than directed (see overdose warning)

    Adults and children 12 years and over

    ■ take 2 tablets every 6 hours while symptoms last.
    ■ do not take more than 6 tablets in 24 hours, unless directed by a doctor

    ■ do not use for more than 10 days unless directed by a doctor

    Children under 12 years Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ■ store at room temperature 59º-86ºF (15º-30ºC)

    ■ tamper-evident sealed packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, hypromellose*, polyethylene glycol*, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid*, titanium dioxide*.

    * may contain

  • QUESTIONS

    Questions or comments? 800-480-5855

  • Unishield Extra Strength Non-Aspirin

    Unishield

    Extra Strength

    Non-Aspirin

    Pain Reliever/Fever Reducer

    100 Tablets/2Tablets Per Packet

    Acetaminophen 500 mg

    Pull To Open

    This Package is for Households Without Young Children.

    • Relieves headaches, backaches, muscular aches and more

    • Temporarily relieves fever

    Compare active ingredients to:

    Extra Strength Tylenol®

    Registered Trademark of McNeil Consumer Healthcare

    Tamper Evident Unit Dose Packets

    175R XS NonAspirin 11133 Rev 2-14-23 LNK

  • Unishield Extra Strength Non-Aspirin Label

    Unishield

    Extra Strength

    Non-Aspirin

    Pain Reliever/Fever Reducer

    100 Tablets/2Tablets Per Packet

    Acetaminophen 500 mg

    Pull To Open

    This Package is for Households Without Young Children.

    • Relieves headaches, backaches, muscular aches and more

    • Temporarily relieves fever

    Compare active ingredients to:

    Extra Strength Tylenol®

    Registered Trademark of McNeil Consumer Healthcare

    Tamper Evident Unit Dose Packets

    175R XS NonAspirin 11133 Rev 2-14-23 Allegiant

    175R NonAspirinXS Label 12-28-20

  • INGREDIENTS AND APPEARANCE
    UNISHIELD EXTRA STRENGTH NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-1773
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code 44;148
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-1773-350 in 1 BOX06/01/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/01/2023
    UNISHIELD EXTRA STRENGTH NON-ASPIRIN 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-1753
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-1753-350 in 1 BOX03/01/202111/01/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/01/202111/01/2023
    UNISHIELD EXTRA STRENGTH NON-ASPIRIN 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-1763
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-1763-350 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
    LNK International, Inc,832867837manufacture(49314-1773)