Dologesic
- Manufacturer
- LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
- Effective date
- 2012-04-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:31:23
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each caplet) Purpose
Acetaminophen ............................. 500 mg .......... Analgesic
Phenyltoloxamine Citrate ............... 30 mg ............ Hay fever relief
OTC - PURPOSE SECTION
Uses
- For the temporary relief of minor aches and pains associated with
- headache
- muscular aches
- backaches
- minor arthritis pain
- common cold
- toothaches
- menstrual cramps
- temporarily reduces fever
- itchy and watery eyes due to hay fever
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/
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 while using this product
OTC - DO NOT USE SECTION
Do not use
- 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
- for more than 10 days for pain, unless directed by a doctor
- for more than 3 days for fever, unless directed by a doctor
- if you have liver disease
- if you are taking the thinning drug warfarin
- 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 present
- These could be signs of a serious condition.
OTC - WHEN USING SECTION
Warnings:
- May cause drowsiness: alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product
- Do not take this product if you are taking sedatives or tranquilizers without consulting a doctor
- Use caution when driving motor vehicles or operating machinery
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If you are pregnant or breast-feeding, ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
| AGE | Dose |
| adults and children 12 years of age and over | take 1 tablet every 4-6 hours. Do not take more than 6 tablets in 24 hours, or as directed by a doctor |
| children under 12 years of age | Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminophen and could cause liver damage |
INDICATIONS & USAGE SECTION
Overdose Warning:Taking more than the recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other information:Store at room temperature 15-30 degrees C (59-86 degrees F).
Tamper Evident: Do not use if there is evidence of tampering.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Povidone, pregelatinized starch, stearic acid, magnesium stearate, silicon dioxide.
OTC - QUESTIONS SECTION
Questions or Comments?1-866-595-5598
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2391564 | acetaminophen 500 MG / phenyltoloxamine citrate 30 MG Oral Tablet | PSN | 1 |
| 2391568 | acetaminophen 500 MG / phenyltoloxamine citrate 30 MG Oral Tablet [Dologesic] | SBD | 1 |
| 2391564 | acetaminophen 500 MG / phenyltoloxamine citrate 30 MG Oral Tablet | SCD | 1 |
| 2391564 | APAP 500 MG / phenyltoloxamine citrate 30 MG Oral Tablet | SY | 1 |
| 2391568 | APAP 500 MG / phenyltoloxamine citrate 30 MG Oral Tablet [Dologesic] | SY | 1 |
| 2391568 | Dologesic (acetaminophen 500 MG / phenyltoloxamine citrate 30 MG) Oral Tablet | SY | 1 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54859-110-10 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b642-f6ea-e053-dbdaa90aa703 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54859-110-10 | DologesicDF | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54859-110-10 | EA - Each | 54859-110 | e92de3fa-413c-442c-b548-dbace22f6244 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| PHENYLTOLOXAMINE CITRATE | ACTIVE INGREDIENT | 8UE48MJH8M | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| PHENYLTOLOXAMINE | ACTIVE MOIETY | K65LB6598J | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Products#
Every source-derived product name is available through these pages.
- Dologesic DF
- Acetaminophen, Phenyltoloxamine Citrate
- ACETAMINOPHEN
- PHENYLTOLOXAMINE CITRATE
- PHENYLTOLOXAMINE
- POVIDONE
- STARCH, CORN
- STEARIC ACID
- MAGNESIUM STEARATE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54859-110 | 54859-110-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PHENYLTOLOXAMINE CITRATE | 8UE48MJH8M | ACTIB |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg |
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 |
|---|---|---|---|---|---|---|
| a19a62af-3dd9-4081-9d47-f72dcda27378 | acc13bbf-7d3b-4e70-a342-757130137852 | 2012-04-10 | Warnings | a19a62af-3dd9-4081-9d47-f72dcda27378 acc13bbf-7d3b-4e70-a342-757130137852 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
