FDA.reportPublic FDA data

Dologesic

Manufacturer
Llorens Pharmaceutical International Division
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:30:25

Label at a glance#

ProductDologesic NF
Active ingredientACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE
Label structure11 sections

Indications and 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

Dosage and administration

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  Age Dose  adults and children 12 years of age and over Take 2 caplets every 4-6 hours...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each caplet)

Acetaminophen 500 mg

Dexbrompheniramine Maleate 1 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

antihistamine

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

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
  • 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 your doctor.
  • Use caution when driving motor vehicle or operating machinery

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

Ask a doctor before use:

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

FD&C Red #40, FD&C Yellow #6, glycerin, hydrocypropyl methyl cellulose, magnesium stearate, microcrystaline cellulose,polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, tricalcium phosphate

Questions or comments

OTC - QUESTIONS SECTION

1-866-595-5598

RECENT MAJOR CHANGES SECTION

Added "itchy and watery eyes due to hay fever" in Uses section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DologesicDologesic

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletPSN8
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletSCD8
1798453APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral TabletSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54859-001-012020-12-23C16284748780-19d75b9d0-99c4-f424-e053-dadaa90a57ceLlorens-Dologesic 001
54859-001-502020-12-23C16284748780-19d75b9d0-99c4-f424-e053-dadaa90a57ceLlorens-Dologesic 001
54859-001-012020-01-31C16284748780-19d75b9d0-99c4-f424-e053-dadaa90a57ceLlorens-Dologesic 001
54859-001-502020-01-31C16284748780-19d75b9d0-99c4-f424-e053-dadaa90a57ceLlorens-Dologesic 001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-001-01DologesicNF100 in 1 BOTTLETABLET1008
54859-001-50DologesicNF50 in 1 BOTTLETABLET508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-001-01EA - Each54859-00100464653-486d-4552-bc14-f57535653ec812016-07-19
54859-001-50EA - Each54859-0010c3d163d-a259-4fa4-bcf6-7ffa6f05d34b12016-07-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54859-00154859-001-01, 54859-001-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYDROXYPROPYL METHYLCELLULOSE3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TALC7SEV7J4R1UIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXBROMPHENIRAMINE MALEATEBPA9UT29BSACTIB
POLYVINYL ALCOHOL532B59J990IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dologesic NFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division974fc0d5-7a99-46fb-af38-b91240f728fa2025-12-31WarningsExact identifier
ndc (package): 54859-001-01
ndc (package): 54859-001-50
ndc (product): 54859-001
ndc11 (package): 54859000101
ndc11 (package): 54859000150
spl id: 47460679-895d-b4d5-e063-6394a90ab919
spl set id: 974fc0d5-7a99-46fb-af38-b91240f728fa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.