FDA Label for Sure Result O3d3 System

View Indications, Usage & Precautions

Sure Result O3d3 System Product Label

The following document was submitted to the FDA by the labeler of this product International Brand Management, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Description



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


Dosage Forms & Strengths



Each capsule provides:

Eicosapentaenoic acid (EPA) ethyl ester: 464 mg

Docosahexaenoic acid (DHA) ethyl ester: 375 mg


Storage And Handling



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].


Dosage & Administration



Usual Dosage:

See package insert for full prescribing information.

Swallow capsules whole.



Package Label.Principal Display Panel




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