Restora RXnone

Other Combinations

Brand: US Pharmaceutical Corporation

CapsuleOther CombinationsOn Market
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Net Contents

30 Capsule(s)

Serving Size

1 Capsule(s)

Servings Per Container

30

Supplement Form

Capsule

Bar Code (UPC/SKU)

3 52747 20730 4

Product Version

Rev. 06/2014

Label Analysis

Objective insights generated automatically from the official DSLD label — a quick, factual read of how this product is formulated and disclosed.

2Active Ingredients

2 distinct active ingredients are disclosed in Supplement Facts.

100%Amount Transparency

Every active ingredient discloses a specific amount per serving.

1% Daily Value Coverage

1 ingredients report a %DV; 1 meet or exceed 100% DV.

This analysis is generated algorithmically from label data for educational reference only. It is not a product endorsement, ranking, or medical advice.

Supplement Facts

Serving Size: 1 Capsule(s) · 1 per day

IngredientAmount Per Serving% Daily Value
Folic Acid1.25 mg313%
Lactobacillus casei KE-9960 mg—

% Daily Value based on 2000 calorie intake for adults and children 12 years and older

Other Ingredients

FD&C Blue #1Flaxseed Oil powderHypromelloseMagnesium StearateMicrocrystalline CelluloseTitanium Dioxide

Target Groups

Adult (18 - 50 Years)

Label Claims

NutrientAll Other

Directions & Suggested Use

Suggested/Recommended/Usage/Directions

Dosage and Administration: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician.

Suggested/Recommended/Usage/Directions

One a day

Warnings & Precautions

Precautions re: All Other

Do not exceed recommended dosage.

Precautions re: Children

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.

Precautions re: Pregnant or Nursing or Prescription Medications

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: All Other

Warning: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

Precautions re: All Other

Precautions: Folic acid in doses above 0.1 mg-0.4 mg daily may obscure the signs and symptoms of pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive. The use of this product immunocompromised patients or treatment of any disorder must be medically supervised by a physician.

Precautions re: All Other

Caution: Rx only.

Storage

Storage

Store at controlled room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F). Keep in a cool, dry place.

Formulation

Formula re: Contains

Nutritional Supplement enhanced with Lactobacillus casei KE-99

Formula re: Contains

Folic Acid: Folic Acid is one of the important hematopoietic agents necessary for proper regeneration of the blood-forming elements and their function. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia.

Formulation re: Other

How supplied: Restora Rx are light blue opaque capsules printed with "US" logo and "R207" in white. Child resistant bottles of 30 capsules NDC #52747-207-30. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Formulation re: Other

Manufactured with Vcaps Plus capsule shells.

FDA Statements

FDA Statement of Identity

Nutritional Supplement enhanced with Lactobacillus casei KE-99

Other Label Statements

General Statements: All Other Content

Rx only NDC 52747-207-30

Brand IP Statement(s) re: (c), (TM), (SM)

Vcaps and the Vcaps Logo are trademarks used under license.

Manufacturer & Distributor

Distributor

US Pharmaceutical Corporation

P.O. Box 360465, Decatur, GA, 30036

Market Reference

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Research & Studies

  • Generation Rx: How prescription drugs are altering American lives, minds, and bodies

    G Critser - 2005 - books.google.com

    … Twenty-five years ago, as this book will demonstrate, most drug company executives … It was true that the studies proving the case for patent restoration laws that would give pharma …

    2005134 citations
  • Narrative review: the FDA's perfunctory approach of dietary supplement regulations giving rise to copious reports of adverse events

    WQ Li, A Wertheimer - Innovations in Pharmacy, 2023 - pmc.ncbi.nlm.nih.gov

    … products, the FDA is not authorized to review dietary supplement products for their safety … the United States consume these dietary supplements in efforts to maintain or improve health, …

    202320 citations
  • Determinants of market exclusivity for prescription drugs in the United States

    AS Kesselheim, MS Sinha, J Avorn - JAMA internal medicine, 2017 - jamanetwork.com

    … Policy makers frequently try to lengthen these periods to increase pharmaceutical company … involved in clinical testing by creating a period of patent term restoration. This Act permitted …

    2017104 citations
  • Risks, benefits, and competitive interference: consumer perceptions of prescription drug versus dietary supplement advertising

    MB Royne, SD Myers, G Deitz… - Journal of Current Issues & …, 2016 - Taylor & Francis

    … ads for both a prescription drug (Viagra) and dietary supplement (Enzyte), … health risks for the prescription drug and higher levels of perceived hedonic benefits for the dietary supplement…

    201625 citations
  • Dietary supplement adverse event reports: review and analysis

    AR Talati, AK Gurnani - Food and Drug Law Journal, 2009 - JSTOR

    … events occurring as a result of consuming dietary supplements. The Act further required labels of supplements marketed in the United States to include "a domestic address or domestic …

    20097 citations
  • Efficacy of a new prescription-only medical food supplement in alleviating signs and symptoms of dry eye, with or without concomitant cyclosporine A

    MA Jackson, K Burrell, IB Gaddie… - Clinical …, 2011 - Taylor & Francis

    … to take two soft geltabs of the medical food supplement by mouth twice daily for 6 months. Group 2 (n = 20) was directed to take the medical food supplement in the same manner, along …

    201142 citations

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: 264523. 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.