Label: EASYFAST- acetaminophen capsule
- NDC Code(s): 83174-613-26
- Packager: Easyfast Supplements LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 17, 2023
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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.
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INGREDIENTS AND APPEARANCE
EASYFAST
acetaminophen capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83174-613 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape OVAL Size 21mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83174-613-26 2 in 1 PACKET; Type 0: Not a Combination Product 04/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/2023 Labeler - Easyfast Supplements LLC (101607110)
