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Dologesic DF by Llorens Pharmaceutical International Division

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DEXBROMPHENIRAMINE MALEATE 1mg
Labeler: Llorens Pharmaceutical International Division
NDC Code: 54859-010

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.

Active Ingredients

(in each caplet)

Acetaminophen 500 mg

Dexbrompheniramine Maleate 1 mg

Purpose

Pain reliever/fever reducer

antihistamine

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

Warnings

Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take

  • more than 8 capsules in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminphen
  • 3 or more alcoholic drinks every day while using this product

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.

Do not use

  • with any other drug containing acetaminphen (prescription or non-prescription). If you are not sure whether a drug contains acetaminphen 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
  • May cause drowsiness: alcohol, sedative and tranquilizers may increase the drowsiness effect Avoid alcoholic beverages while taking this product
  • Do not take this product if you are taking sedative or tranquilizers without consulting your doctore
  • Use cauting when driving motor vehicle or operating machinery.

Ask a doctor or pharmacist before use: 

  • if you are taking the blood thinning drug warafin
  • if you have liver disease

Stop using this product and ask a doctor if:

  • pain gets worse or last more than 10 days
  • fever gets worse or last more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • these could be signs of a serious condition

Keep out of reach of children

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

Directions

Overdose Warning: Taking more than 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

Do not exceed recommended dosage

 AgeDose
 adults and children 12 years of age and overTake 2 caplets every 4-6 hours. Do not take more than 8 caplets 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 acetaminphen and could cause liver damage

Inactive ingredients

magnesium stearate, microcrystaline cellulose, sodium starch glycolate, tricalcium phosphate

Questions or comments

1-866-595-5598

DOLOGESIC  DF
acetaminophen, dexbrompheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DEXBROMPHENIRAMINE MALEATE (DEXBROMPHENIRAMINE) DEXBROMPHENIRAMINE MALEATE1 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
TRICALCIUM PHOSPHATE 
Product Characteristics
ColorwhiteScoreno score
ShapecapsuleSize20mm
FlavorImprint CodeLLORENS
Contains    
Packaging
#Item CodePackage Description
1NDC:54859-010-01100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/2016
Labeler - Llorens Pharmaceutical International Division (037342305)

 
Llorens Pharmaceutical International Division

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Medically reviewed on Jun 25, 2018

Further information

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

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