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Dologesic

Medically reviewed on June 19, 2018

Dosage form: liquid
Ingredients: ACETAMINOPHEN 500mg in 15mL, PHENYLTOLOXAMINE CITRATE 30mg in 15mL, ALCOHOL 0.75mL in 15mL
Labeler: Llorens Pharmaceutical International Division
NDC Code: 54859-512

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 Facts

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


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

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 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. 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.

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

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

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 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 or Comments? 1-866-595-5598

Llorens International Division, Miami, Fl 33166

DOLOGESIC 
acetaminophen, phenyltoloxamine citrate, alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-512
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 15 mL
PHENYLTOLOXAMINE CITRATE (PHENYLTOLOXAMINE) PHENYLTOLOXAMINE CITRATE30 mg  in 15 mL
ALCOHOL (ALCOHOL) ALCOHOL0.75 mL  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
ALCOHOL 
GLYCERIN 
FD&C YELLOW NO. 6 
MENTHOL 
METHYLPARABEN 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
WATER 
SUCROSE 
Packaging
#Item CodePackage Description
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)

 
Llorens Pharmaceutical International Division

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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