Indications and uses
Temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
Temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours; do not exceed 48 tablets in 24 hours children under 12 years: consult a doctor
store between 20°-25°C (68°-77°F) in a dry place retain carton for complete product information
Drug Facts
| Active Ingredients | Purposes |
| Acetaminophen 250 mg................................. | Pain reliever |
| Aspirin 250 mg (NSAID*)................................ | Pain reliever |
| Caffeine 65 mg................................................. | Pain reliever aid |
* nonsteroidal anti-inflammatory drug
Temporarily relieves minor aches and pains due to:
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Acetaminophen may cause severe skin reactions. Symptoms may include:
Aspirin may cause a severe allergic reaction which may include:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Caffeine warning: 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.
If pregnant or breast-feeding, ask a health
professional before use. It is especially important not
to use aspirin during the last 3 months of pregnancy
unless definitely directed to do so by a doctor because
it may cause problems in the unborn child or
complications during delivery.
Keep out of reach of children. 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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
This product contains acetaminophen.
Severe liver damage may occur if you take
maximum daily amount
product
carnauba wax, colloidal
silicon dioxide, hypromellose, microcrystalline
cellulose, mineral oil, povidone, pregelatinized starch,
sodium starch glycolate, stearic acid, titanium dioxide
1-866-359-3478 (M-F) 9AM to 5PM EST
or
www.pharmadel.com
DOLEX®
FORTE
EXTRA STRENGTH
Acetaminophen, Aspirin ,Caffeine
Pain reliever/Pain reliever Aid
24 Caplets
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55758-019 | 55758-019-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POVIDONE | FZ989GH94E | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
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 |
|---|---|---|---|---|---|---|
| f901e46e-9385-f6db-e053-6294a90ada5d | 7424c92f-2d28-70c1-e053-2991aa0aab43 | 2023-04-10 | Warnings | 7424c92f-2d28-70c1-e053-2991aa0aab43 |
Adverse event summaries are temporarily unavailable. Other product information remains available.