Label: DOLOGESIC- acetaminophen, phenyltoloxamine citrate, alcohol liquid

  • Category: HUMAN OTC DRUG LABEL

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 June 19, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients in each tablespoonful (15 mL)           Purpose

    Acetaminophen, USP .................... 500 mg/15mL......................Pain Reliever/Fever Reducer

    Phenyltoloxamine Citrate, USP ........ 30 mg/15mL......................Pain Reliever

    Alcohol, USP....................................... 5%...............................Pharmaceutical Aid


  • PURPOSE

    Uses

    • for the temporary relief of minor aches and pains associated with
      • headache
      • backache
      • muscular aches
      • premenstrual and menstrual cramps
      • the common cold and flu
      • toothache
      • for minor pains from arthritis
      • temporarily reduces fever

  • WARNINGS

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

    Acetaminophen may cause liver damage.


    When using this product

    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol and sedatives may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Ask a doctor before use if you are

    • taking tranquilizers or sedatives
    Ask a doctor before use if you have
    • glaucoma
    • emphysema
    • asthma
    • chronic pulmonary disease
    • trouble urinating due to an enlarged prostate gland
    Stop use and ask a doctor if
    • pain persists for more than 10 days, or redness is present, or in conditions affecting children 12 years of age, consult a physician immediately
    • if relief does not occur within 3 days, discontinue use and consult a physician
  • DO NOT USE

    Do not give to children under 3 years of age or more use for more than 10 days unless directed by a physician

    Do not take this product for more than 10 days and do not take for fever for more than 3 days unless directed by a physician


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of 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.

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions Do not exceed 8 tablespoons in any 24-hour period or as directed by a doctor

    adults and children 12 years of age and older
    take 1 or 2 tablespoons every 4 to 6 hours
    children under 12 years of age
    Consult a physician; do not give this product to children
    under 12 years of age. This product will provide more than the
    recommended dose (overdose) of non-aspirin and could cause
    serious health problems
  • INDICATIONS & USAGE

    Other information store at controlled room temperature 20 - 25 degrees C (68 - 77 degrees F); excursions permitted to 15 - 30 degrees C (59 - 86 degrees F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.


  • INACTIVE INGREDIENT

    Inactive ingredients:Citric Acid, Ethanol (5 percent by volume), FD and C Yellow Number 6, Glycerin, Menthol, Methylparaben, Peach Flavor, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water and Sugar.

  • QUESTIONS

    Questions or Comments? 1-866-595-5598

    Llorens International Division, Miami, Fl 33166

  • PRINCIPAL DISPLAY PANEL

    dologesicliquid

  • INGREDIENTS AND APPEARANCE
    DOLOGESIC 
    acetaminophen, phenyltoloxamine citrate, alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-512
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
    PHENYLTOLOXAMINE CITRATE (UNII: 8UE48MJH8M) (PHENYLTOLOXAMINE - UNII:K65LB6598J) PHENYLTOLOXAMINE CITRATE30 mg  in 15 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-512-06177 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/01/1994
    Labeler -  Llorens Pharmaceutical International Division (037342305)