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Fda.gov/AboutFDA/CentersOffices/CDER/ucm090142. htm. REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA 21 CFR 314. Pdf. As required under 21 CFR 314. 81 b 3 i you must submit final promotional materials and the package insert at the time of initial dissemination or publication accompanied by a Form FDA 2253. 5 grams Generic or Proper Name acetylcysteine Sponsor Arbor Pharmaceuticals LLC Approval Date January 29 2016 Indication For...
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Find a clean glass or container.
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Fill the glass or container with water or any beverage that does not contain alcohol.
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Place one CETYLEV effervescent tablet in the glass or container.
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Stir the solution gently if necessary.
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Drink the solution immediately after the tablet has dissolved.

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CETYLEV effervescent tablets are commonly used by individuals who have difficulty swallowing or have a restricted fluid intake.
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Cetylev effervescent tablets are used to help prevent or reduce the severity of liver damage caused by an overdose of acetaminophen (Tylenol).
Cetylev effervescent tablets are not filed by individuals, but rather prescribed by healthcare professionals for patients who have overdosed on acetaminophen.
Cetylev effervescent tablets are typically administered orally by dissolving the tablet in water and drinking the solution. Dosage instructions should be followed as directed by a healthcare professional.
The purpose of cetylev effervescent tablets is to help prevent or reduce liver damage in patients who have overdosed on acetaminophen.
The information reported on cetylev effervescent tablets may include the patient's name, dosage instructions, date of administration, and any adverse reactions experienced.
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