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

  • NDC Code(s): 49314-1753-3, 49314-1763-3
  • Packager: Unishield
  • 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 March 3, 2023

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  • 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, maltodextrin*, microcrystalline cellulose*, 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

  • 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

    Non-Aspirin

  • INGREDIENTS AND APPEARANCE
    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 not finalpart34303/01/202111/01/2023
    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 not finalpart34303/01/2021
    Labeler - Unishield (790677053)
    Registrant - Unifirst First Aid Corporation (832947092)
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