RESTORA- lactobacillus casei ke-99 enhanced with omega-3 capsule

RESTORA by

Drug Labeling and Warnings

RESTORA by is a Other medication manufactured, distributed, or labeled by U.S. PHARMACEUTICAL CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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 30036

Available at your local pharmacy.

Order Restora at your local pharmacy.
All pharmacies can order Restora usually within 24 hours.

available on amazon

buy direct at myRestora.com

uspco.com

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.

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

INGREDIENTS AND APPEARANCE

RESTORA 
lactobacillus casei ke-99 enhanced with omega-3 capsule

Product 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)