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Product NDC Code | 83174-613 | ||||
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Drug Name | Easyfast |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | CAPSULE | ||||
RxCUI drug identifier | 349113 | ||||
Application Number | M013 | ||||
Labeler Name | Easyfast Supplements LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each capsule) Acetaminophen 500 mg
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 children12 years and older: • take 1 capsule every 3-4 hours, or 2 capsules every 6 hours, while symptoms persist • do not exceed 8 capsules in 24 hours • or as directed by a doctor. • Children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Micro Crystalline Cellulose (MCC)
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: • the common cold • headache • toothache • muscular aches • backache • premenstrual and menstrual cramps • arthritis • temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.Easyfast Acetaminophen ACETAMINOPHEN ACETAMINOPHEN MICROCRYSTALLINE CELLULOSE
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 capsules
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
2 delayed-release capsules Manufactured for: Easyfast Supplements Brooklyn, NY 11229 Made in the USA Please email us: [email protected]
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? +1-516-399-0613 You may also report serious side effects to this phone number. Monday-Friday, 9:00 am-4:30 pm
Storage and handling
Information about safe storage and handling of the drug product.Other information • store between 20-25º C (68-77º F) • do not use if foil pouch is open or broken
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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 capsules 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 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. 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. • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present • symptoms do not improve If pregnant or breast-feeding, ask a health professional before use. 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