Duralgina

Manufacturer
Menper Distributors Inc. | DRLZ
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:36:00

Label at a glance#

ProductDuralgina
Active ingredientACETAMINOPHEN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

Acetaminophen 325 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/Fever reducer

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of minor aches and pains associated with 

  • headache
  • muscular aches
  • minor arthritis pain
  • menstrual cramps
  • common cold
  • temporarily reduces fever
  • backaches
  • toothaches

WARNINGS SECTION

Warnings:

Liver warning:

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

  • more than12 tablets in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day.

Do not use:

  • with any other drug conatining 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.

Ask a doctor before use if you have liver disease

Ask a docor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop using this product and ask a 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 persistent
  • These could be signs of a serious condition

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Do not take more than directed (see overdose warning)
 Adults and children12 years and over Take 2 tablets every 4-6 hours as needed. Do not take more than 12 tablets in 24 hours, unless directed by a doctor
 Children ages 6-11 Take 1 tablet every 4-6 hours as needed. Do not take more than 6 tablets in 24 hours, unless directed by a doctor
 Under 6 years of age Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients Magnesium stearate, povidone, silicone dioxide, sodium carboxymethyl, starch, stearic acid

OTC - QUESTIONS SECTION

Questions: Call 1-800-560-5223 M-F 9AM - 4PM Eastern

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN11
313782acetaminophen 325 MG Oral TabletSCD11
313782APAP 325 MG Oral TabletSY11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130042279108056GTIN-13: 0042279108056
EAN-13: 0042279108056
GTIN-12: 042279108056
UPC-A: 042279108056
GTIN storage (14 digits): 00042279108056
Durolgina.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-013-712020-01-31C16284748780-19d75b9d0-b84e-f424-e053-dadaa90a57ceDuralgina

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-013-71Duralgina30 in 1 BOTTLETABLET3011

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-01353145-013-71

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
DuralginaACETAMINOPHENMenper Distributors Inc.bb31f66c-80a9-4bdb-983b-cef5d21de5ff2025-07-22WarningsExact identifier
ndc (package): 53145-013-71
ndc (product): 53145-013
ndc11 (package): 53145001371
spl id: 3a893b13-e7ee-c5b1-e063-6394a90a4253
spl set id: bb31f66c-80a9-4bdb-983b-cef5d21de5ff

Reported adverse events (FAERS/openFDA)#

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