Label: RESTORA- lactobacillus casei ke-99 enhanced with omega-3 capsule
- NHRIC Code(s): 52747-200-30
- Packager: U.S. PHARMACEUTICAL CORPORATION
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated August 26, 2022
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STATEMENT OF IDENTITY
Supplement Facts
Serving Size: 1 Capsule
Servings Per Carton: 30
Amount Per Serving %DV Omega-3 Fish Oil 400 mg † Omega-3 Fatty Acids 120 mg † EPA (Eicosapentaenoic Acid) 64 mg † DHA (Docosahexaenoic Acid) 40 mg † Other Omega-3 Fatty Acids 16 mg † Lactobacillus Casei (KE-99) 4 billion CFUs** † † Daily Value not established Other Ingredients: Gelatin, silica, and natural mixed tocopherols.
**Colony Forming Units (CFUs) are a measure of viable cells, unlike direct cell counts which includes all cells, dead and alive. -
WARNINGS
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). DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
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PRECAUTIONS
Precautions: As with other nutritional supplements, consult a physician if you are taking medications, diabetic, are pregnant or nursing; keep out of reach of children and pets. 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.
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SAFE HANDLING WARNING
Store at or below room temperature 15° to 30°C (59° to 86° F). Do not expose to excessive heat, humidity or direct sunlight.
How Supplied: Restora™ are blue-green or teal opaque gelatin capsules printed with "US" Logo and "R200" in white. Available in box of 30 blisterpacked capsules (52747-0200-30). The listed product number is not a National Drug Code. Instead, US Pharmaceutical Corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.
Rev.04/2022
Marketed by
US Pharmaceutical Corporation,
P.O.Box 360465, Decatur, GA 30036Available at your local pharmacy.
Order Restora at your local pharmacy.
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DOSAGE & ADMINISTRATION
Dosage and Administration: Adults and children (ages 12 years and older), one (1) capsule daily, orally, or as prescribed by a physician.
Do not exceed recommended dosage. Do not administer to children under the age of 12. 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.
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HEALTH CLAIM
Nutritional Supplement
Lactobacillus Casei KE-99 enhanced with Omega-3
restore and protect your digestive and immune system naturally against occasional*
√ Constipation
√ Gas and Bloating
√ Diarrhea
1 A DAY
U.S. Patent No:6,797,266 and 7,214,370
*
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
SUPERIOR MOISTURE PROTECTION ACID RESISTANT
ENHANCED GROWTH GLUTEN FREE
PROFESSIONAL PROBIOTIC SUPPLEMENT
To support strong, healthy Digestive and Immune systems.* - Packaging
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INGREDIENTS AND APPEARANCE
RESTORA
lactobacillus casei ke-99 enhanced with omega-3 capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:52747-200 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F) FISH OIL 400 mg LACTICASEIBACILLUS CASEI (UNII: SA940P2U00) (LACTICASEIBACILLUS CASEI - UNII:SA940P2U00) LACTICASEIBACILLUS CASEI 45 mg Inactive Ingredients Ingredient Name Strength FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) TOCOPHEROL (UNII: R0ZB2556P8) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:52747-200-30 3 in 1 BOX 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 07/27/2015 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color color shape size (solid drugs) 22 mm scoring 1 Labeler - U.S. PHARMACEUTICAL CORPORATION (079467662)
