ALGESIS- chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane, boswellia serrata extract, ginger root extract, turmeric, devils claw root, vitamin c, vitamin d, folic acid tablet 
Solubiomix

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Algesis

HEALTH CLAIM:

Algesis Tablets Dietary Supplement

Dispensed by Prescription

Supplement Facts
Serving Size: 2 Tablet

Servings per Bottle: 15

Amount Per Serving:% Daily Value
Vitamin C (as ascorbic acid) 100 mg 111%
Vitamine D (as cholecalciferol) 3000 mg 7500%
Folic Acid 500 mg 250%
Chondroitin Sulfate 500 mg *
Glucosamine Sulfate 400 mg *
Methylsulfonylmethane 180 mg *
Boswellia Serrata Extract 100 mg*

Ginger Root Extract

Turmeric (curcumin)

Devil’s Claw Root

100 mg

100 mg

20 mg

*

*

*

*Daily Values (DV) not established.

OTHER INGREDIENTS:  cellulose, magnesium stearate, and silicon dioxide.

DESCRIPTION:

Algesis Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

WARNING AND PRECAUTIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Algesis tablets should only be used under the direction and supervision of a licensed medical practitioner.  Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.


Pregnancy and Lactation
Algesis is not intended for use in pregnant or lactating patients.

DOSAGE & ADMINISTRATION

Usual adult dose is 1 serving (2 tablets) two or three times daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED HEALTH CLAIM:

Algesis tablets are supplied as grey, oblong shaped tablets with imprint “S41”in a child-resistant bottle of 30ct. (69499-341-30*)

Dispensed by Prescription

*Solubiomix does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

† This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx).  This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable.  The ingredients, indication or claims of this product are not to be construed to be drug claims.

  1. Federal Register Notice of August 2, 1973 (38 FR 20750)
  2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
  3. Federal Register Notice of March 5, 1996 (61 FR 8760)

STORAGE AND HANDLING:

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

Protect from heat, light and moisture.

KEEP OUT OF THE REACH OF CHILDREN.

Tamper Evident: Do not use if seal is broken or missing.

Algesis Label:

image description

ALGESIS 
chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane, boswellia serrata extract, ginger root extract, turmeric, devils claw root, vitamin c, vitamin d, folic acid tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69499-341
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) (CONDOLIASE - UNII:7SI2UZG934) CHONDROITIN SULFATE (BOVINE)250 mg
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) (GLUCOSAMINE - UNII:N08U5BOQ1K) GLUCOSAMINE SULFATE250 mg
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) (DIMETHYL SULFONE - UNII:9H4PO4Z4FT) DIMETHYL SULFONE200 mg
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) (INDIAN FRANKINCENSE - UNII:4PW41QCO2M) INDIAN FRANKINCENSE50 mg
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414) (ZINGIBER OFFICINALE WHOLE - UNII:IN6Q3S3414) ZINGIBER OFFICINALE WHOLE50 mg
TURMERIC (UNII: 856YO1Z64F) (TURMERIC - UNII:856YO1Z64F) TURMERIC50 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID50 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1500 [iU]
HARPAGOSIDE (UNII: 8KGS1DC5ZU) (HARPAGOSIDE - UNII:8KGS1DC5ZU) HARPAGOSIDE10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID.5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69499-341-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement06/26/201802/01/2019
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
shape
imprint
size (solid drugs)19 mm
scoring1
Labeler - Solubiomix (079640556)

Revised: 2/2019
 
Solubiomix