Label: ULINE ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 69790-126-33, 69790-154-33, 69790-173-33, 69790-804-33
  • Packager: Uline
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 30, 2024

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  • Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    Temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • minor arthritis pain
    • backache
    • 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

    • 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 a doctor before use if you have

    • liver disease
  • Ask a doctor or pharmacist before use if you have

    • liver disease
  • Stop use and ask a doctor if

    • pain gets worse or lasts 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.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • 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.

  • Directions

    • do not use more than directed (see overdose warning)

    Adults and children: (12 years and over)

    Take 2 tablets every 6 while symptoms last. Do not take more than 6 tablets in 24 hours, unles 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 information

    • store at room temperature 59º-86ºF (15º-30ºC)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • Inactive ingredients

    corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid, titanium dioxide*

    * May contain

  • Questions or comments?

    1-800-295-5510

  • Uline Acetaminophen Extra Strength Label

    ULINE

    Tamper evident sealed packets:

    Do not use if packet is open or torn.

    This package is for households without young children

    Acetaminophen

    Pull to Open

    Extra Strength

    500 mg

    • Pain Reliever

    • Fever Reducer

    50 Packets

    2 tablets Each

    175R S-18593BX 11-6-23 Label 1

  • Uline Acetaminophen Extra Strength Label

    ULINE

    Tamper evident sealed packets:

    Do not use if packet is open or torn.

    This package is for households without young children

    Acetaminophen

    Pull to Open

    Extra Strength

    500 mg

    • Pain Reliever

    • Fever Reducer

    50 Packets

    2 tablets Each

    175R S-18593BX 11-6-23 Label 2

  • Uline Acetaminohen Extra Strength Label

    ULINE

    Tamper evident sealed packets:

    Do not use if packet is open or torn.

    This package is for households without young children

    Acetaminophen

    Pull to Open

    Extra Strength

    500 mg

    • Pain Reliever

    • Fever Reducer

    50 Packets

    2 tablets Each

    175R S-18593BX 11-6-23 Label 3

  • PRINCIPAL DISPLAY PANEL

    ULINE

    Tamper evident sealed packets:

    Do not use if packet is open or torn.

    This package is for households without young children

    Acetaminophen

    Pull to Open

    Extra Strength

    500 mg

    • Pain Reliever

    • Fever Reducer

    50 Packets

    2 tablets Each

    175R Uline Acetaminophen XS Uline 11-28-22

  • INGREDIENTS AND APPEARANCE
    ULINE ACETAMINOPHEN EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69790-173
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code 44;148
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69790-173-3350 in 1 BOX01/30/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/30/2024
    ULINE ACETAMINOPHEN EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69790-804
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69790-804-3350 in 1 BOX10/07/2019
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01310/07/2019
    ULINE ACETAMINOPHEN EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69790-126
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69790-126-3350 in 1 BOX10/07/201911/01/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01310/07/201911/01/2023
    ULINE ACETAMINOPHEN EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69790-154
    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)  
    POVIDONE K30 (UNII: U725QWY32X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorwhite ((White to Off-White)) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code G552
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69790-154-3350 in 1 BOX01/30/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/30/2024
    Labeler - Uline (039612668)
    Registrant - Unifirst First Aid Corporation (832947092)
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