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| Product NDC Code | 55758-306 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Dolex 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 | Pharmadel 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 and Purposes Active ingredients Purposes Acetaminophen 250 mg................... Pain reliever Aspirin (NSAID*) 250 mg ................ Pain reliever Caffeine 65 mg................................. Pain reliever aid/ diuretic * nonsteroidal anti-inflammatory drug
| Acetaminophen 250 mg................... | Pain reliever |
| Aspirin | Pain reliever |
| Caffeine 65 mg................................. | Pain reliever aid/ diuretic |
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 adults and children 12 years and over: two (2) caplets every 6 hours with a full glass of water with each dose. Do not exceed; adults 8 caplets and children 6 caplets in 24 hours . children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
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 a cold arthritis muscular aches toothache premenstrual and menstrual cramps and bloating
Purpose
Information about the drug product’s indications for use.Active ingredients Purposes Acetaminophen 250 mg................... Pain reliever Aspirin (NSAID*) 250 mg ................ Pain reliever Caffeine 65 mg................................. Pain reliever aid/ diuretic * nonsteroidal anti-inflammatory drug
| Acetaminophen 250 mg................... | Pain reliever |
| Aspirin | Pain reliever |
| Caffeine 65 mg................................. | Pain reliever aid/ diuretic |
Spl product data elements
Usually a list of ingredients in a drug product.Dolex Forte Acetaminophen, Aspirin, Caffeine ACETAMINOPHEN ACETAMINOPHEN PROPYLENE GLYCOL CROSPOVIDONE POVIDONE SODIUM LAURYL SULFATE HYPROMELLOSE, UNSPECIFIED CELLULOSE, MICROCRYSTALLINE STEARIC ACID TITANIUM DIOXIDE ASPIRIN ASPIRIN STARCH, CORN CAFFEINE CAFFEINE SODIUM STARCH GLYCOLATE TYPE A (Capsule-Shaped Tablet) 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.Principal Display Panel PDP DFORTE
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 Drug Facts
Distributed by / Distribuido por: PHARMADEL LLC New Castle, DE, 19720
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if the user has liver disease has a history of stomach problems, such as heartburn has high blood pressure, heart disease, liver cirrhosis, or kidney disease takes a diuretic has not been drinking fluids has lost a lot of fluid due to vomiting or diarrhea is a child with pain of arthritis has asthma
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor before use if a stomach bleeding warning applies to user
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if the user has 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.
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. Prompt 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? 1-866-359-3478 (M-F) 9AM to 5PM EST or www.pharmadel.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. users experience any of the following signs of stomach bleeding: feel faint vomit blood has bloody or black stools has stomach pain that does not get better ringing in the ears or loss of hearing occurs taking a prescription drug for diabetes, gout, or arthritis adult's pain gets worse or lasts for more than 10 days child's pain gets worse or lasts for more than 5 days fever gets worse or lasts for more than 3 days redness or swelling is present new symptoms occur
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 68°-77°F (20°-25°C) read all product information before using. Keep box for important information.
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: Aspirin (NSAID) 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 adult takes more than 4 doses in 24 hours, which is the maximum daily amount child takes more than 3 doses in 24 hours taken with other drugs containing acetaminophen adult has 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 the user: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed has 3 or more alcoholic drinks everyday 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 a rapid heartbeat. Do not use if the user has 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 the user has liver disease has a history of stomach problems, such as heartburn has high blood pressure, heart disease, liver cirrhosis, or kidney disease takes a diuretic has not been drinking fluids has lost a lot of fluid due to vomiting or diarrhea is a child with pain of arthritis has asthma Ask a doctor before use if a stomach bleeding warning applies to user Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. users experience any of the following signs of stomach bleeding: feel faint vomit blood has bloody or black stools has stomach pain that does not get better ringing in the ears or loss of hearing occurs taking a prescription drug for diabetes, gout, or arthritis adult's pain gets worse or lasts for more than 10 days child's pain gets worse or lasts for more than 5 days fever gets worse or lasts for more than 3 days redness or swelling is present new symptoms occur 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.
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