DOLOGESIC DF- acetaminophen, dexbrompheniramine maleate tablet 
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.

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Active Ingredients

(in each caplet)

Acetaminophen 500 mg

Dexbrompheniramine Maleate 1 mg

Purpose

Pain reliever/fever reducer

antihistamine

Uses

Warnings

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

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

Ask a doctor or pharmacist before use: 

Stop using this product and ask a doctor if:

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

dologesicDF

DOLOGESIC  DF
acetaminophen, dexbrompheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE1 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
Product Characteristics
ColorwhiteScoreno score
ShapecapsuleSize20mm
FlavorImprint Code LLORENS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-010-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/2016
Labeler - Llorens Pharmaceutical International Division (037342305)

Revised: 12/2020
Document Id: 83ec16e9-3cd3-4d2e-8abe-494a28c65cb9
Set id: 55768b45-fd98-4779-85b6-6a50c628677e
Version: 4
Effective Time: 20201223
 
Llorens Pharmaceutical International Division