Label: DOLEX ACETAMINOPHEN 500MG EXTRA STRENGTH- acetaminophen capsule, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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  • Drug Facts

  • Active ingredient & Purpose

    Active ingredient (in each caplet)Purpose
    Acetaminophen 500 mgPain reliever/ fever reducer
  • Uses

    For the temporary relief of minor aches and pains due to:

    • the common cold
    • headache
    • backache
    • muscular aches
    • toothache
    • minor pain of arthritis
    • premenstrual and menstrual cramps
    • temporarily reduces fever
  • Warnings

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

    • more than 4000mg in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    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 allergic to 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 are

    taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms occur

    These could be signs of a serious condition.

    If pregnant or breast feeding,

    Keep out of reach of children.

    Keep out of reach of children.

    Overdose warning:

    In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed (see OVERDOSE WARNING)

    ​

    AgeDose
    adults and children 12 years of age and over
    • take 2 caplets, every 6 hours while symptoms last.
    • do not take more than 6 caplets 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 of age
    • consult a doctor

  • Other information

    • store at room temperature 77-86°F (25-30°C)
  • Inactive ingredients

    corn starch,hypromellose,magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone k90, stearic acid, titanium dioxide

  • Distributed by:

    PHARMADEL LLC.

    New Castle, DE 19720

    1-866-359-3478

  • Prinicipal Display Panel

    Rapidol PDP

  • INGREDIENTS AND APPEARANCE
    DOLEX ACETAMINOPHEN 500MG  EXTRA STRENGTH
    acetaminophen capsule, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-372
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM CITRATE (UNII: RHO26O1T9V)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Capsule-Shaped Tablet) Size18mm
    FlavorImprint Code AP500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-372-241 in 1 CARTON04/07/2023
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/07/2023
    Labeler - Pharmadel LLC (030129680)
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