Duralgina

Duralgina
SPL v11
SPL
SPL Set ID bb31f66c-80a9-4bdb-983b-cef5d21de5ff
Route
ORAL
Published
Effective Date 2017-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Magnesium Stearate Povidone Silicon Dioxide Carboxymethylcellulose Sodium Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 555 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-01
Description

Active Ingredient (in each tablet) Acetaminophen 325 mg

Medication Information

Warnings and Precautions

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
Indications and Usage

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
Dosage and Administration

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

Description

Active Ingredient (in each tablet) Acetaminophen 325 mg

Section 50565-1

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.

Section 51727-6

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

Section 51945-4

Section 53413-1

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

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/Fever reducer

Section 55106-9

Active Ingredient (in each tablet)

Acetaminophen 325 mg

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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
Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/Fever reducer

Section 55106-9 (55106-9)

Active Ingredient (in each tablet)

Acetaminophen 325 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.990419 · Updated: 2026-03-14T23:12:42.073607