Easyfast Capsule
FDA Label NDC 83174-613
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Easyfast Supplements Llc for the product Easyfast (NDC 83174-613). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient (in each capsule), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Capsule)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
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
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.
Otc - Keep Out Of Reach Of Children
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.
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
Other Information
• store between 20-25° C (68-77° F) • do not use if foil pouch is open or broken
Inactive Ingredients
Micro Crystalline Cellulose (MCC)
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
Packaging
Capsules (83174613 01)
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