Indications and uses
For the temporary relief of minor aches and pains due to: toothache headache and to reduce fever
DoloDent Toothache
- Manufacturer
- Pharmadel LLC
- Effective date
- 2024-09-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:19:55
Label at a glance#
ProductDoloDent Toothache For adults
Active ingredientCAFFEINE, ACETAMINOPHEN
Label structure10 sections
Dosage and administration
do not take more than directed (see OVERDOSE WARNING) adults and children 12 years of age and older: take 2 tablets, every 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours children under 12 years of age: do not use
Storage and handling
store between 68°-77°F (20°-25°C)
Contacts and useful links#
Websitewww.pharmadel.com
www.pharmadel.com
www.pharmadel.comLabel contents#
Full prescribing information#
Drug Facts
Drug Facts
Active ingredients and Purposes
OTC - PURPOSE SECTION
| Active ingredients | Purposes |
| Acetaminophen 500 mg................... | Pain reliever/fever reducer |
| Caffeine 65 mg................................. | Pain reliever aid |
Uses
For the temporary relief of minor aches and pains due to:
- toothache
- headache
- and to reduce fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash. If a skin reaction occurs, stop use and seek medical help right away.
Caffeine: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine -containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
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 allergic to any of the ingredients in this product
- on children under 12 years of age
Ask a doctor before use if you have
- liver disease
Ask a doctor before use if you are
- taking the blood thinning drug warfarin
Stop use and ask a doctor or dentist if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
If pregnant or breastfeeding,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
OVERDOSE WARNING: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a 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.
Directions
- do not take more than directed (see OVERDOSE WARNING)
- adults and children 12 years of age and older: take 2 tablets, every 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours
- children under 12 years of age: do not use
Other information
- store between 68°-77°F (20°-25°C)
Inactive ingredients
croscarmellose sodium, microcrystalline cellulose 101, povidone k30, silicon dioxide, stearic acid, water
Questions?
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Distributed by / Distribuido por:
PHARMADEL LLC
New Castle, DE, 19720
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-435-24 | DoloDent ToothacheFor adults | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 55758-435-24 | DoloDent ToothacheFor adults | 24 in 1 BOTTLE | TABLET | 24 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- DoloDent Toothache For adults
- Acetaminophen, Caffeine
- CROSCARMELLOSE SODIUM
- CROSCARMELLOSE
- POVIDONE K30
- MICROCRYSTALLINE CELLULOSE 101
- STEARIC ACID
- SILICON DIOXIDE
- WATER
- CAFFEINE
- ACETAMINOPHEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-435 | 55758-435-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| MICROCRYSTALLINE CELLULOSE 101 | 7T9FYH5QMK | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| WATER | 059QF0KO0R | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
| 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 |
|---|---|---|---|---|---|---|
| DoloDent Toothache For adults | ACETAMINOPHEN, CAFFEINE | Pharmadel LLC | 1e7a0c06-ad3c-b94f-e063-6394a90abab1 | 2024-09-19 | Warnings | 55758-435-24 55758-435 55758043524 227ba7f7-a051-50ad-e063-6394a90a74d6 1e7a0c06-ad3c-b94f-e063-6394a90abab1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.