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| Product NDC Code | 27854-303 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sedalmex forte |
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| Type | Brand | ||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 308297 | ||||||
| Application Number | M013 | ||||||
| Labeler Name | Belmora LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each tablet) Acetaminophen 250 mg Aspirin (NSAID*) 250 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • 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
| Take 2 Tablets every 6 hours as needed; not more than 8 tablets in 24 hours | |
| Ask a doctor | |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves minor aches and pains due to: • headache • muscular aches • arthritis pain • a cold • toothache • premenstrual and menstrual cramps
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer Pain reliever/fever reducer Pain reliever aid
Spl product data elements
Usually a list of ingredients in a drug product.SEDALMEX FORTE Acetaminophen, Aspirin, Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POVIDONE K30 POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN STEARIC ACID TALC WHITE TO OFF WHITE WITH SPECKS CAPSULE SHAPED BICONVEX S53
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-888-779-2877 M-F 9AM-5PM EST
Storage and handling
Information about safe storage and handling of the drug product.Other information • 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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 (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 pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days ringing in the ears or loss of hearing occurs painful area is red or swollen any new symptoms occur 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API