Azalgia: Package Insert and Label Information

AZALGIA- ascorbic acid, calcium, manganese carbonate, folic acid, shark cartilage, glucosamine sulfate, dimethyl sulfone, indian frankincense, turmeric and chicken cartilage capsule
Basiem, LLC

HEALTH CLAIM:

AZALGIA Capsules — Dietary Supplement

Dispensed by Prescription

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OTHER INGREDIENTS: Gelatin, magnesium stearate, maltodextrin

DESCRIPTION:

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


AZALGIA is manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that have been approved by the U.S. Food and Drug Administration (FDA) as food additives or are “Generally Recognized as Safe” (GRAS) for their intended use.

AZALGIA should be administered under the supervision of a licensed medical practitioner.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease.

WARNING AND PRECAUTIONS

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


KEEP OUT OF REACH OF CHILDREN

PRECAUTION
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. AZALGIA capsules should only be used under the direction and supervision of a licensed medical practitioner.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling 1-844-551-9911 or the FDA by calling 1-800-FDA-1088.

DOSAGE & ADMINISTRATION

Usual adult dose is 2 capsules taken orally once or twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED HEALTH CLAIM:

AZALGIA Dietary Supplement
Capsules are clear with a yellow powder inside
Bottles contain 60 capsules, 69597-354-60*
Dispensed by Prescription

Manufactured in USA for:
Basiem, LLC
Madisonville, LA 70447


Distributed by: Solubiomix, LLC
Rev. 04/2020


* Basiem 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.
The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product by prescription. 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:

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

PACKAGE LABEL:

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AZALGIA
ascorbic acid, folic acid, calcium, manganese, shark cartilage, glucosamine sulfate, msm, boswella serrata, tumeric extract, chicken cartilage capsule
Product Information
Product Type Item Code (Source) NDC:69597-354
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 25 mg
CALCIUM (CALCIUM) CALCIUM 17.5 mg
MANGANESE CARBONATE (MANGANESE CATION (2+)) MANGANESE CATION (2+) 1.25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 0.5 mg
SHARK CARTILAGE (SHARK CARTILAGE) SHARK CARTILAGE 248 mg
GLUCOSAMINE SULFATE (GLUCOSAMINE) GLUCOSAMINE SULFATE 175 mg
DIMETHYL SULFONE (DIMETHYL SULFONE) DIMETHYL SULFONE 37.5 mg
INDIAN FRANKINCENSE (INDIAN FRANKINCENSE) INDIAN FRANKINCENSE 12.5 mg
TURMERIC (TURMERIC) TURMERIC 12.5 mg
CHICKEN CARTILAGE (CHICKEN CARTILAGE) CHICKEN CARTILAGE 2 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
CALCIUM STEARATE
SILICA DIMETHYL SILYLATE
MALTODEXTRIN
Product Characteristics
Color yellow (Yellow powder in clear capsule) Score no score
Shape capsule Size 21mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69597-354-60 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 04/08/2020
Labeler — Basiem, LLC (079686680)

Revised: 04/2020 Basiem, LLC

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