DOLOGESIC DF- acetaminophen, phenyltoloxamine citrate tablet 
LLORENS PHARMACEUTICALS 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 caplet)               Purpose

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

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

Uses

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

Do not use

Ask a doctor before use:

Stop using this product and ask doctor if:

Warnings:

Keep out of reach of children.


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

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

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.


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

Questions or Comments?1-866-595-5598

DologesicDFLabel

DOLOGESIC  DF
acetaminophen, phenyltoloxamine citrate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PHENYLTOLOXAMINE CITRATE (UNII: 8UE48MJH8M) (PHENYLTOLOXAMINE - UNII:K65LB6598J) PHENYLTOLOXAMINE CITRATE30 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize20mm
FlavorImprint Code LLORENS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-110-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/01/2009
Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Revised: 4/2012
Document Id: a19a62af-3dd9-4081-9d47-f72dcda27378
Set id: acc13bbf-7d3b-4e70-a342-757130137852
Version: 1
Effective Time: 20120410
 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION