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
- 2025-08-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:35:10
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 over: take two (2) caplets every 6 hours with a glass of water. Do not take more than 6 caplets 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 and read before using.
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Drug Facts
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
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 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 6 caplets 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
- 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
- you have asthma
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 occur.
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. 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 over: take two (2) caplets every 6 hours with a glass of water. Do not take more than 6 caplets 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 and read before using.
Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Distributed by / Distribuido por:
Pharmadel LLC
New Castle, DE 19720
Questions? +1-866-359-3478
Made in India / Hecho en India
Principal Display Panel
Products#
Every source-derived product name is available through these pages.
- Dolex Forte
- Acetaminophen, Aspirin, Caffeine
- ACETAMINOPHEN
- PROPYLENE GLYCOL
- CROSPOVIDONE
- POVIDONE
- SODIUM LAURYL SULFATE
- HYPROMELLOSE, UNSPECIFIED
- CELLULOSE, MICROCRYSTALLINE
- STEARIC ACID
- TITANIUM DIOXIDE
- ASPIRIN
- STARCH, CORN
- CAFFEINE
- SODIUM STARCH GLYCOLATE TYPE A
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-306 | 55758-306-24, 55758-306-02, 55758-306-50, 55758-306-99 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | 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 |
|---|---|---|---|---|---|---|
| 3c1c5ead-3e5a-88f5-e063-6294a90a1280 | f9012cfa-9184-ec4c-e053-6294a90a6810 | 2025-08-11 | Warnings | 3c1c5ead-3e5a-88f5-e063-6294a90a1280 f9012cfa-9184-ec4c-e053-6294a90a6810 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.