Ofirmev (acetaminophen)
Product Images NDC 51662-1424

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Ofirmev (acetaminophen) (NDC 51662-1424). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hf Acquisition Co Llc, Dba Healthfirst, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Adverse (Adverse)

A data table titled 'Treatment-Emergent Adverse Reactions Occurring in ≥ 3% of OFIRMEV-treated Adult Patients and at a Greater Frequency than Placebo in Placebo-Controlled, Repeated Dose Studies.' The table compares adverse reaction frequencies between OFIRMEV (N=402) and placebo (N=379) across different system organ classes including gastrointestinal, general disorders, nervous system, and psychiatric disorders with terms like nausea, vomiting, pyrexia, headache, and insomnia listed with their respective n (%) values.*

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Boxed Warning (Boxed Warning)

A warning text panel titled 'RISK OF MEDICATION ERRORS AND HEPATOTOXICITY' for OFIRMEV Injection. It advises careful prescribing, preparing, and administering OFIRMEV to avoid dosing errors leading to overdose and death. Key points include correct dose measurement, dosing based on weight for patients under 50 kg, proper infusion pump programming, and not exceeding maximum daily acetaminophen dose. It notes acetaminophen-related liver failure risks, sometimes requiring liver transplant or causing death.*

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Clinical Studies (Clinical Studies)

A line graph comparing mean temperature (°C) over time post dose (hours) between intravenous acetaminophen and placebo groups. The graph shows temperature decreasing over 6 hours with IV acetaminophen, indicated by filled circles, compared to a higher temperature trend for placebo, indicated by open circles.*

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Clinical P (Clinical)

Data table titled 'Table 5. OFIRMEV Pharmacokinetic Parameters' presenting mean (SD) values of pharmacokinetic measures for OFIRMEV in three subpopulations: Children, Adolescents, and Adults. Parameters include AUC₀-6h (µg·h/mL), Cmax (µg/mL), T1/2 (h), CL (L/h/kg), and Vss (L/kg). Values vary slightly among the subpopulations.*

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Dosage 1 (Dosage 1)

Dosing table for adults and adolescents aged 13 years and older showing acetaminophen dosing guidelines based on weight and frequency. It includes dose given every 4 hours, every 6 hours, maximum single dose, and maximum total daily dose by all routes for patients weighing 50 kg or more and those weighing less than 50 kg.*

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Dosage 2 (Dosage 2)

A dosing table for children aged 2 to 12 years showing acetaminophen dose guidelines. It lists doses given every 4 hours (12.5 mg/kg), every 6 hours (15 mg/kg), maximum single dose (15 mg/kg up to 750 mg), and maximum total daily dose (75 mg/kg in 24 hours up to 3750 mg).*

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Dosage 3 (Dosage 3)

A dosing table for treatment of fever in neonates and infants, showing age groups (Neonates: birth to 28 days; Infants: 29 days to 2 years), the dose given every 6 hours in mg/kg, and the maximum total daily dose of acetaminophen by all routes in mg/kg.*

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Highlights (Highlights 1)

A drug warning panel for OFIRMEV (acetaminophen) highlighting the risk of medication errors and hepatotoxicity, advising careful prescribing and administration to avoid overdose and liver damage. It also includes a table of recent major changes with dates related to Dosage and Administration updates.*

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Serialized Labeling (Serialized Vial)

OFIRMEV (acetaminophen) injection 1000 mg/100 mL (10 mg/mL) in a single-use vial. Clear liquid visible inside a glass vial with a blue and gray rubber cap. The vial label shows distribution by HF Acquisition Co LLC, Mukilteo, WA, and includes a barcode and QR code. Labeled for intravenous use only.*

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Structure (Structure)

Chemical structure of acetaminophen, showing a benzene ring with hydroxyl group, an amide group, and methyl substitution.*

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Vial Label (Vial Label)

Label for OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL) for intravenous use. It includes dosing instructions, storage conditions (20°C to 25°C), and formulation details. Manufactured for Mallinckrodt Hospital Products Inc., Hazelwood, MO, USA. The label features NDC 43825-102-01 and specifies single-use vial with Rx only.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.