Indications and uses
Temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps and bloating
Dolex Forte
- Manufacturer
- Pharmadel LLC
- Effective date
- 2025-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:26:14
Label at a glance#
ProductDolex Forte
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure9 sections
Dosage and administration
do not take more than directed (See WARNINGS ) adults and children 12 years of age and older: take two (2) tablets every 6 hours with a full glass of water. Do not take more than 8 tablets in 24 hours. children under 12 years of age: consult a doctor
Storage and handling
store between 68-77˚F (20-25˚C) keep box for important information read all product information before use
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients and Purposes
.
OTC - PURPOSE SECTION
| Active ingredients | Purposes |
| Acetaminophen 250 mg................... | Pain reliever |
| Aspirin 250 mg (NSAID*)................ | Pain reliever |
| Caffeine 65 mg................................. | Pain reliever aid |
* nonsteroidal anti-inflammatory drug
Drug Facts
.
Uses
Temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- toothache
- premenstrual and menstrual cramps and bloating
Warnings
Reye’s syndrome: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.
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.
Allergy alert: Aspirin (NSAID) may cause severe allergic reactions. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
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
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
Stomach bleeding warning:This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks everyday while using this product
- take more or for a longer time than directed
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 a rapid heartbeat.
Do not use
- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
- with any other drug containing acetaminophen(prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
- you have liver disease
- you have asthma
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are taking
- a prescription drug for diabetes, gout, or arthritis
- any other drug, or are under a doctor's care for any serious condition
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or loss of hearing occurs
- redness or swelling is present
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- any new symptoms appear.
These could be signs of a serious condition.
If pregnant or breastfeeding,
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). 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 WARNINGS)
- adults and children 12 years of age and older:take two (2) tablets every 6 hours with a full glass of water. Do not take more than 8tablets in 24 hours. children under 12 years of age:consult a doctor
Other information
- store between 68-77˚F (20-25˚C)
- keep box for important information
- read all product information before use
Inactive ingredients
corn starch, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone k30, silicon dioxide, stearic acid, talc, water
Dist. by/ por:
Pharmadel LLC
New Castle, DE 19720
Questions? +1-866-359-3478
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-509-02 | Dolex Forte | 2 in 1 PACKET | TABLET | 2 | 2 | |
| 55758-509-24 | Dolex Forte | 1 in 1 CARTON | TABLET | 1 | 2 | |
| 55758-509-24 | Dolex Forte | 24 in 1 BOTTLE | TABLET | 24 | 2 | |
| 55758-509-50 | Dolex Forte | 25 in 1 BOX | TABLET | 25 | 2 |
Products#
Every source-derived product name is available through these pages.
- Dolex Forte
- Acetaminophen, Aspirin, Caffeine
- POLYETHYLENE GLYCOL 400
- TALC
- STARCH, CORN
- SILICON DIOXIDE
- POVIDONE K30
- HYPROMELLOSE, UNSPECIFIED
- CELLULOSE, MICROCRYSTALLINE
- STEARIC ACID
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-509 | 55758-509-24, 55758-509-02, 55758-509-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| Dolex Forte | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Pharmadel LLC | 3c2d90fc-130d-476c-e063-6294a90a8c15 | 2025-12-17 | Warnings | 55758-509-50 55758-509-24 55758-509-02 55758-509 55758050950 55758050902 55758050924 462857bf-e00b-287d-e063-6294a90aa93b 3c2d90fc-130d-476c-e063-6294a90a8c15 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.