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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0042279108056 | GTIN-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 | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53145-013-71 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b84e-f424-e053-dadaa90a57ce | Duralgina |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53145-013-71 | Duralgina | 30 in 1 BOTTLE | TABLET | 30 | 11 |
Products#
Every source-derived product name is available through these pages.
- Duralgina
- Acetaminophen
- MAGNESIUM STEARATE
- POVIDONE
- SILICON DIOXIDE
- CARBOXYMETHYLCELLULOSE SODIUM
- STARCH, CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53145-013 | 53145-013-71 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Duralgina | ACETAMINOPHEN | Menper Distributors Inc. | bb31f66c-80a9-4bdb-983b-cef5d21de5ff | 2025-07-22 | Warnings | 53145-013-71 53145-013 53145001371 3a893b13-e7ee-c5b1-e063-6394a90a4253 bb31f66c-80a9-4bdb-983b-cef5d21de5ff |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
