Indications and uses
temporarily relieves minor aches and pains due to: • headache • muscular aches • arthritis pain • a cold • toothache • premenstrual and menstrual cramps
temporarily relieves minor aches and pains due to: • headache • muscular aches • arthritis pain • a cold • 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 older) Take 2 Tablets every 6 hours as needed; not more than 8 tablets in 24 hours Children under 12 years: Ask a doctor
• read all product information before using. Keep box for important information. • store at room temperature between 68°-77°F (20°-25°C) • avoid excessive heat and humidity • tamper evident sealed packets • do not use any opened or torn packets • each tablet contains: Magnesium 0.58 mg
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Pain reliever/fever reducer
Pain reliever aid
temporarily relieves minor aches and pains due to:
• headache • muscular aches • arthritis pain
• a cold • toothache • premenstrual and menstrual cramps
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 (NSAIDs) may cause a severe allergic reaction which 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 every day while using this product
Stomach bleeding warning: This product contains an 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)
• take more or for a longer time than directed
• have 3 or more alcoholic drinks every day while using this product
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 heart beat.
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• If you ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/fever reducers
Ask a doctor before use if
• stomach bleeding warning applies to you
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic • you have a history of stomach problems, such as heartburn
• you have asthma • you have liver disease
Ask a doctor or pharmacist before use if you are
• if you are taking prescription drug for gout, diabetes, or arthritis
• taking any other drug, or 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
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin at 20 weeks or later in 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
• do not use more than directed
• drink a full glass of water with each dose
(12 years and older) | Take 2 Tablets every 6 hours as needed; not more than 8 tablets in 24 hours |
| Children under 12 years: | Ask a doctor |
• read all product information before using. Keep box for important information.
• store at room temperature between 68°-77°F (20°-25°C)
• avoid excessive heat and humidity
• tamper evident sealed packets
• do not use any opened or torn packets
• each tablet contains: Magnesium 0.58 mg
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc
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Fast Headache Relief!
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
Distributed by
Belmora LLC, 3033 Wilson BLvd.,
Suite 700. Arlington, VA 22201,
MADE IN INDIA
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 27854-303-01 | SEDALMEX FORTE | 40 in 1 BOX | TABLET | 40 | 1 | |
| 27854-303-01 | SEDALMEX FORTE | 1 in 1 PACKET | TABLET | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 27854-303 | 27854-303-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
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 |
|---|---|---|---|---|---|---|
| SEDALMEX FORTE | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Belmora LLC | 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d | 2024-02-28 | Warnings | 27854-303-01 27854-303 27854030301 8987ddc4-ae5c-4a2a-85b4-e73e63d195fc 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d |
Adverse event summaries are temporarily unavailable. Other product information remains available.