DOLOGESIC - acetaminophen, phenyltoloxamine citrate, alcohol liquid 
Llorens Pharmaceutical International Division

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

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

Ask a doctor before use if you are

Ask a doctor before use if you have
Stop use and ask a doctor if

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

dologesicliquid

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)

Revised: 6/2012
Document Id: 8d059a3b-2fb4-4801-a50a-e0eeca2cb4fc
Set id: 738e7767-42de-4076-acf2-9152484c2007
Version: 1
Effective Time: 20120619
 
Llorens Pharmaceutical International Division