Duralgina Extra Strength

Manufacturer
Menper Distributors, Inc.
Effective date
2026-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-15 00:33:03

Label at a glance#

ProductDuralgina Extra Strength
Active ingredientACETAMINOPHEN
Label structure14 sections

Indications and uses

For the temporary relief of minor aches and pains associated with: headache muscular aches minor arthritis pain menstrual cramps common cold backaches toothaches temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 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.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with:

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

temporarily reduces fever

Liver warning

WARNINGS SECTION

This product contains acetaminophen. Severe liver damage may occur if you take more than 12 tablets in 24 hours, with other drugs containing acetaminophen, 3 or more alcoholic drinks every day.

Do not use

OTC - DO NOT USE SECTION

  • 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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
  • adults and children 12 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.

Other information

OTHER SAFETY INFORMATION

  • store between 68-77°F (20-25°C)
  • do not use if safety seal is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

magnesium stearate, povidone, silicon dioxide, sodium carboxymethyl starch, starch, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-83053145-830-30

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
Duralgina Extra StrengthACETAMINOPHENMenper Distributors, Inc.544e3d7e-a759-384f-e063-6294a90a5baa2026-06-15WarningsExact identifier
ndc (package): 53145-830-30
ndc (product): 53145-830
ndc11 (package): 53145083030
spl id: 544e3d7e-a75a-384f-e063-6294a90a5baa
spl set id: 544e3d7e-a759-384f-e063-6294a90a5baa

Reported adverse events (FAERS/openFDA)#

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