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- INGREDIENTS AND APPEARANCE
BIOVEN naja naja strip PRODUCT INFORMATION Product Type HUMAN OTC DRUG Item Code (Source) NDC:69569-001 Route of Administration ORAL ACTIVE INGREDIENT/ACTIVE MOIETY Ingredient Name Basis of Strength Strength NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM – UNII:ZZ4AG7L7VM) NAJA NAJA VENOM 10 [hp_X] INACTIVE INGREDIENTS Ingredient Name Strength CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) SUCROSE (UNII: C151H8M554) THIMEROSAL (UNII: 2225PI3MOV) ORANGE OIL (UNII: AKN3KSD11B) PACKAGING # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69569-001-01 15 in 1 POUCH; Type 0: Not a Combination Product 02/15/2015 MARKETING INFORMATION Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/15/2015 LABELER – RED MOUNTAIN, INC. (614758857) ESTABLISHMENT Name Address ID/FEI Business Operations Red Mountain, Inc. 614758857 repack(69569-001)
Dosage BIOVEN is taken sublingual (under the tongue) in doses of I tab (0.1 ml) each day for a minimum of 15 days or until effective. The severity of the disease will determine the total number of doses. Upward of 90 dose) have been given when necessary without any harmful systemic side effects. Directions for use BIOVEN is administered sub-lingual under the tongue. The dose is 0.1 ml(cc) per tab dosage form. If the BIOVEN is accidentally swallowed (not sublingual) it will not be effective. BIOVEN should be administered daily in the recommended doses of one (1)tab (0.1 ml) for at least 15 days (or doses) or until positive results are obtained or the treatment discontinued. The duration of treatment or the number of doses depends upon the severity of the condition. Some patients have received over 90 doses when necessary without any harmful side effects. If more than the recommended dose (0.1 ml) of BIOVEN is administered no harm will result. Some patients have received as much as 4 tabs without any harmful systemic side effects. However, the larger doses are no more effective than the recommended dose of 1 tab. Indications BIOVEN has been reported to be very effective in the treatment of such conditions as Rheumatoid Arthritis, Herpes Zoster (Shingles),Herpes Kerititis (ophthalmic), Herpes Simplex and immune disorders such as Lupis. Action The exact mode of action of BIOVEN is unknown at present. Current research indicates that its effectiveness is due to enzymatic and/or immunologic action. Reactions None systemically. If the patient is highly allergic or sensitive, oral administration of a low dose OTC anti-histamine prior to the dose tab may be helpful. Extensive animal tests demonstrated no ill effects even after receiving five (5) times the normal human dose. Teratogenic studies showed no genetic changes in at least five generations. Precautions This product is not intended for use in children, pregnant or nursing females . Toxicity None. doses containing as much as 1 ml of BIOVEN in laboratory mice and 2 ml in humans demonstrated no deleterious systemic effects. Shelf Life 18 months stored at 40-85°F temperature.