The following Structured Product Label (SPL) was submitted to the FDA by International Brand Management, Llc for the product Sure Result O3d3 System (NDC 69837-700). 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 description, dosage forms & strengths, storage and handling, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Each capsule contains 1 gram of Omega-3-acid ethyl
esters liquid concentrate consisting of at least 900 mg of
Omega-3-acid ethyl esters.
Omega-3-Acid
Ethyl Esters
Capsules, USP
30 Capsules
1 Gram
Rx Only
PHARMACIST: Dispense the enclosed
Patient Information Leaflet to each patient
Enter section text here
Each capsule provides:
Eicosapentaenoic acid (EPA) ethyl ester: 464 mg
Docosahexaenoic acid (DHA) ethyl ester: 375 mg
Store in tight, light-resistant containers at 25C (77F);
excursions permitted to 15-30C (59-86F)[see USP
Controlled Room Temperature]. Protect from light. Do not
freeze.
Keep out of reach of children.
Dispense in a tight, light-resistant container [see USP].
Usual Dosage:
See package insert for full prescribing information.
Swallow capsules whole.
Copy Of Label (Omega Kit)
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