Label: DOLOGESIC DF- acetaminophen and phenyltoloxamine citrate tablet 

  • NDC Code(s): 54859-110-10
  • Packager: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/12

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each caplet)               Purpose

    Acetaminophen ............................. 500 mg .......... Analgesic

    Phenyltoloxamine Citrate ............... 30 mg ............ Hay fever relief

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  • PURPOSE

    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
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  • WARNINGS

    Warnings

    Alcohol Warning:If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers/

    Liver Warning: This product contains Acetaminophen, Sever liver damage may occur if you take

    • more than 6 tablets 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
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  • DO NOT USE

    Do not use

    • with any other drug containing acetaminophen (prescription or non-prescription).
      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
    • for more than 3 days for fever, unless directed by a doctor
    Ask a doctor before use:

    • if you have liver disease
    • if you are taking the thinning drug warfarin
    Stop using this product and ask 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.
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  • WHEN USING

    Warnings:

    • May cause drowsiness: alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product
    • Do not take this product if you are taking sedatives or tranquilizers without consulting a doctor
    • Use caution when driving motor vehicles or operating machinery
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.


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  • PREGNANCY OR BREAST FEEDING

    If you are pregnant or breast-feeding, ask a health professional before use.

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  • DOSAGE & ADMINISTRATION

    Directions: Do not exceed recommended dosage
    AGE
    Dose
    adults and children 12 years of age and over
    take 1 tablet every 4-6 hours.
    Do not take more than 6 tablets in 24 hours,
    or as directed by a doctor
    children under 12 years of age
    Do not use in children under 12 years of age.
    This will provide more than the recommended dose
    (overdose) of acetaminophen and could cause liver damage
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  • INDICATIONS & USAGE

    Overdose Warning:Taking more than the recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or 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.



    Other information:Store at room temperature 15-30 degrees C (59-86 degrees F).

    Tamper Evident: Do not use if there is evidence of tampering.


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  • INACTIVE INGREDIENT

    Inactive Ingredients: Povidone, pregelatinized starch, stearic acid, magnesium stearate, silicon dioxide.

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  • QUESTIONS

    Questions or Comments?1-866-595-5598

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  • INGREDIENTS AND APPEARANCE
    DOLOGESIC  DF
    acetaminophen, phenyltoloxamine citrate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54859-110
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    PHENYLTOLOXAMINE CITRATE (PHENYLTOLOXAMINE) PHENYLTOLOXAMINE CITRATE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE  
    STARCH, CORN  
    STEARIC ACID  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    Product Characteristics
    Color white Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code LLORENS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54859-110-10 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 09/01/2009
    Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
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