Your browser does not support JavaScript! DOLOGESIC DF (ACETAMINOPHEN, PHENYLTOLOXAMINE CITRATE) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]
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DOLOGESIC DF (acetaminophen, phenyltoloxamine citrate) tablet
[LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Active Ingredients (in each caplet)               Purpose

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

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

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

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

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.

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

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 DRUG LABELItem Code (Source)NDC:54859-110
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PHENYLTOLOXAMINE CITRATE (PHENYLTOLOXAMINE) PHENYLTOLOXAMINE CITRATE30 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, CORN 
STEARIC ACID 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
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
 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

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