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

  • 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 April 7, 2023

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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 not finalpart34304/07/2023
    Labeler - Pharmadel LLC (030129680)
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