Label: ACTIDOGESIC DF- acetaminophen, dexbrompheniramine maleate tablet

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

Drug Label Information

Updated October 10, 2023

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

  • Drug Facts

  • Active Ingredients (in each caplet)

    Acetaminophen, 500 mg

    Dexbrompheniramine Maleate, 1 mg

  • Purpose

    Pain reliever/Fever reducer

    Antihistamine

  • INDICATIONS & USAGE

    Uses • For the temporary relief of minor aches and pains associated with • headache • muscular aches • backaches • minor arthritis pain • common cold • toothaches • menstrual cramps • temporarily reduces fever • itchy and watery eyes due to hay fever.

  • Warnings

    Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 caplets (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 

    Caution: May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. 

    Do not use • with any other drug containing acetaminophen (prescription or non-prescription) this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. 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 the product • for more than 10 days for pain, unless directed by a doctor.

    Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.

    Ask a doctor before use 

    • if you have liver disease • if you are taking the blood thinning drug warfarin.

    Stop using this product and ask a doctor if

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

    Keep out of reach of children.

  • Directions • Do not exceed recommended dosage

    Adults and children

    12 years of age and 

    older

    Take 2 caplets every 4 to 6 hours as needed,

    do not exceed 8 caplets in 24 hours, or as

    directed by a doctor, do not use for more than

    10 days unless directed by a doctor.

    Children under 12  
    years of age
     Do not use.

  • Other Information

    • Tamper Evident. Do not use if inner seal is torn, broken, or missing

    • Store at controlled room temperature 15°- 30°C (59°- 86°F)

    • Avoid excessive heat or humidity

  • INACTIVE INGREDIENT

    Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

  • SPL UNCLASSIFIED SECTION

    • ANALGESIC • FEVER REDUCER

    • ANTIHISTAMINE

    Contains the same active ingredients as Dologesic® - DF*

    SUGAR FREE

    DYE FREE

    ActiPharma

    COMMITTED TO HEALTH AND WELL-BEING

    Manufactured in the USA

    for ActiPharma, Inc.

    Dorado, PR 00646.

    Tel: (787) 608-0882

    * Dologesic® - DF is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ACTIDOGESIC DF 
    acetaminophen, dexbrompheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapecapsuleSize17mm
    FlavorImprint Code A403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63102-403-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/10/2020
    Labeler - Actipharma, Inc (079340948)