Dolofin
- Manufacturer
- Menper Distributors Inc. | Lex Inc.
- Effective date
- 2017-10-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:52:47
Label at a glance#
ProductDolofin
Active ingredientACETAMINOPHEN
Label structure10 sections
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:
Alcohol warning:
- if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
Liver warning:
This product contains acetaminophen. Sever liver damage may occur if you take
- more than 6 tablets in 24 hours, which is the maximum daily amount
- 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.
- 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 warfarin.
Stop using this product and ask a doctor if:
- symptoms do not improve
- pain or fever persists or get worse
- New symptoms occur
- Redness or swelling is present
- These could be signs of a serious condition
OTC - PREGNANCY OR BREAST FEEDING SECTION
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all drugs out of the 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 6 tablets in 24 hours
| Adults and children12 years and over | Take 1 tablet every 4-6 hours as needed, or as directed by a doctor. |
| Children under 12 years | Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminophen and could cause liver damage. |
INACTIVE INGREDIENT SECTION
Inactive ingredients Dicalcium phosphate, microcrystalline cellulose, povidone, silicon dioxide, sodium carboxy methyl starch, stearic acid, talc
OTC - QUESTIONS SECTION
Questions: Call 1-800-560-5223 M-F 9AM - 4PM Eastern
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | 1 |
| 1986337 | Dolofin 325 MG Oral Tablet | PSN | 1 |
| 1986337 | acetaminophen 325 MG Oral Tablet [Dolofin] | SBD | 1 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | 1 |
| 313782 | APAP 325 MG Oral Tablet | SY | 1 |
| 1986337 | APAP 325 MG Oral Tablet [Dolofin] | SY | 1 |
| 1986337 | Dolofin 325 MG Oral Tablet | SY | 1 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53145-420-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8da9-f424-e053-dadaa90a57ce | 07ec0eb1-75b7-4f2e-8c58-9d90f10c9849 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53145-420-30 | Dolofin | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Dolofin
- Acetaminophen
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- MICROCRYSTALLINE CELLULOSE
- POVIDONE
- SILICON DIOXIDE
- CARBOXYMETHYLCELLULOSE SODIUM
- STARCH, CORN
- STEARIC ACID
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53145-420 | 53145-420-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
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 |
|---|---|---|---|---|---|---|
| 58252991-1ad6-4125-b680-9c0f90f46c51 | 07ec0eb1-75b7-4f2e-8c58-9d90f10c9849 | 2017-10-24 | Warnings | 58252991-1ad6-4125-b680-9c0f90f46c51 07ec0eb1-75b7-4f2e-8c58-9d90f10c9849 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.