Net Contents
30 Capsule(s)
Serving Size
1 Capsule(s)
Servings Per Container
30
Supplement Form
Capsule
Bar Code (UPC/SKU)
Not specified
Product Version
Rev. 04/2018
Label Analysis
Objective insights generated automatically from the official DSLD label — a quick, factual read of how this product is formulated and disclosed.
2 distinct active ingredients are disclosed in Supplement Facts.
Every active ingredient discloses a specific amount per serving.
Label states: Gluten-Free.
This analysis is generated algorithmically from label data for educational reference only. It is not a product endorsement, ranking, or medical advice.
Allergen Guide
Contains
- Milk
- Fish
- Shellfish
- Soy
Free From
- Gluten
Allergen flags are parsed automatically from the official label's claims and statements. Always verify against the physical product label before use, especially if you have a severe allergy.
Supplement Facts
Serving Size: 1 Capsule(s) · 1 per day
| Ingredient | Amount Per Serving | |
|---|---|---|
| Omega-3 Fish Oil | 400 mg | — |
| Omega-3 Fatty Acids | 120 mg | — |
| Eicosapentaenoic Acid | 64 mg | — |
| Docosahexaenoic Acid | 40 mg | — |
| Omega-3 Fatty Acids | 16 mg | — |
| Lactobacillus casei KE-99 | — | — |
Not Present
Other Ingredients
Target Groups
Label Claims
Directions & Suggested Use
Suggested/Recommended/Usage/Directions
1 a day
Suggested/Recommended/Usage/Directions
Dosage and Administration: Adults and children (ages 12 years and older), one (1) capsule daily, orally, or as prescribed by a physician.
Warnings & Precautions
Precautions re: All Other
Do not exceed recommended dosage.
Precautions re: Children
Do not administer to children under the age of 12.
Precautions re: All Other
You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036. Warning: Ingestion of more than 3 grams of Omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased bleeding time and INR (International normalized ratio).
Precautions re: Pregnant or Nursing or Prescription Medications
DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. Precautions: As with other nutritional supplements, consult a physician if you are taking medications, diabetic, are pregnant or nursing, keep out of the reach of children and pets.
Precautions re: Children
Precautions: As with other nutritional supplements, consult a physician if you are taking medications, diabetic, are pregnant or nursing, keep out of the reach of children and pets.
Precautions re: Allergies
Contains fish (anchovy and/or sardines, mackerel, jack mackerel), shellfish (shrimp and/or crab, lobster) and soy. May contain trace levels of derivatives from milk. Capsules made from gelatin.
Storage
Storage
Store at or below room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees). Do not expose to excessive heat, humidity or direct sunlight.
Formulation
Formulation re: Other
To support strong, healthy Digestive and Immune systems.
Formula re: Contains
Lactobacillus Casei KE-99 enhanced with Omega-3
Formulation re: Other
Restore and protect your digestive and immune system naturally against occasional Constipation Gas and bloating Diarrhea
Formulation re: Other
Superior moisture protection Acid resistant Enhanced growth
Formulation re: Does NOT Contain
Gluten Free
Formulation re: Other
Made in USA in an FDA registered manufacturing facility.
FDA Statements
FDA Statement of Identity
Professional Probiotic Supplement Nutritional Supplement
FDA Disclaimer Statement
These statements have bot been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
Other Label Statements
Brand IP Statement(s) re: (c), (TM), (SM)
U.S. Patent No: 6,797,266 and 7,214,370
General Statements: All Other Content
To re-order, please contact your Local Pharmacy or go to www.myRestora.com
Manufacturer & Distributor
Distributor
US Pharmaceutical Corporation
P.O. Box 360465, Decatur, GA, 30036
Market Reference
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Where to Buy Locally
Enter your city or ZIP code to find supplement & health stores in your area that may carry this product.
Showing representative supplement & health retailers — search above for stores in your area.
Inspired Health Apothecary
5.0 (5)Vitamin & supplements store
550 SW Industrial Way Bldg 2, Suite100, Bend, OR 97702
LeSante Nutrition
5.0 (6)Vitamin & supplements store
70 SW Century Dr #100-403, Bend, OR 97702
Max Nutrition Bend
4.8 (20)Vitamin & supplements store
61445 S Hwy 97 A, Bend, OR 97702
Natural Grocers
4.4 (448)Vitamin & supplements store
3188 N Hwy 97 #115, Bend, OR 97703
GNC
3.4 (56)Vitamin & supplements store
61334 S Hwy 97 #410, Bend, OR 97702
Whole Formulas
Health food store
20739 High Desert Ct, Bend, OR 97701
Research & Studies
Overview of the Hatch-Waxman Act and its impact on the drug development process
GJ Mossinghoff - Food and Drug Law Journal, 1999 - JSTOR
… term restoration bill became a patent term restoration and drug … , a generic drug company could not bring a drug to mar ket … data exclusivity period for supplements requiring clinical trials. …
1999428 citationsGovernment regulation of health claims in food labeling and advertising
PB Hutt - Food, Drug, Cosmetic Law Journal, 1986 - JSTOR
… of cases against unwarranted health claims for dietary supplement products.41 Examples … "protein supplements are unnecessary for most Americans" because "the US Public Health …
198694 citationsThe case of the missing device patents, or: why device patents matter
E Lietzan, KML Acri, E Weidner - … Intellectual Property, Media …, 2023 - ir.lawnet.fordham.edu
… our study of medical device patent term restoration and our … , the FDA may not disclose a drug company’s research data—… term restoration for both its original PMA and a supplement to …
20236 citationsPatents, product exclusivity, and information dissemination: how law directs biopharmaceutical research and development
RS Eisenberg - 2003 - repository.law.umich.edu
… For one thing, differences in drug regulation make it hard to get imports into US and other … of dietary supplements to obtain FDA approval before labeling supplements with health claims)…
2003120 citationsThe problem of new uses
RS Eisenberg - 2005 - repository.law.umich.edu
… For example, dietary supplements sold in health food stores … of US patent protection was changed in 1995 to bring US law … the Drug Price Competition and Patent Term Restoration Act …
2005212 citationsDietary supplement adverse event reports: review and analysis
AR Talati, AK Gurnani - Food and Drug Law Journal, 2009 - JSTOR
… supplements. The Act further required labels of supplements marketed in the United States to … consumers and third parties such as family members of or healthcare providers for those …
20097 citations
Related News
Data sourced from the U.S. National Institutes of Health, Office of Dietary Supplements Dietary Supplement Label Database (DSLD) · Label entered 2021-12-18. DSLD Label ID: 264519. This information is provided for educational reference only and is not medical advice. Always follow the product label and consult a doctor or pharmacist before use.
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