RENO CAPS- reno caps capsule

RENO CAPS by

Drug Labeling and Warnings

RENO CAPS by is a Other medication manufactured, distributed, or labeled by Nnodum Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Reno Caps are black oval softgel imprinted “z622”. These softgels provide water- soluble vitamins.

Active Ingredients:

Each Reno Caps softgel contains:

Vitamin C (Ascorbic Acid)………………………100 mg

Thiamine (as thiamine mononitrate)……………..1.5 mg

Riboflavin………………………………………..1.7 mg

Niacin (as niacinamide)………………………….20 mg

Vitamin B-6 (as pyridoxine Hcl)………………...10 mg

Folate (as folic Acid)…………………………….1 mg

Vitamin B-12 (as cyanocobalam)………………..6 mcg

Biotin……………………………………………..150 mcg

Pantothenic acid (as calcium Pantothenate)……...5 mg

Inactive Ingredients: Gelatin, glycerin, lecithin, soybean oil, yellow beeswax, titanium dioxide, FDC Yellow #6, water, FDC blue #1, FDC Red #40

Health Claim

Reno Caps Softgels is a prescription vitamins supplement indicated for renal disease patients to replace critical vitamins lost due to dialysis in patients with chronic renal disease, uremia and impaired metabolic kidney functions. Also used as a stress vitamin.

Warnings

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

Directions

DIRECTIONS: One soft gel daily or as directed by a physician.

PRECAUTIONS

PRECAUTIONS: Folic acid may mask the symptoms of pernicious anemia in that hematologic remission may occur while neurological manifestations progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

Safe handling

STORAGE: Store at controlled room temperature 15-30o C (59-86o F). Keep container tightly closed and protect from heat and moisture.

Package Label Principal Display Panel

lABEL - Reno Caps 30-Count Bottle

62044-622-30

Reno Caps

Dietary Supplement

Nnodum
Pharmaceuticals

30 Softgels
DO NOT USE IF IMPRINTED SAFETY SEAL
UNDER CAP IS BROKEN OR MISSING

Supplement Facts
Serving Size: 1 Soft Gel

Amount per serving                                   % Daily Value

Vitamin C (Ascorbic Acid)                           100 mg 167%
Thiamine (as thiamine mononitrate)              1.5 mg 100%
Riboflavin                                                1.7 mg 100%
Niacin (as niacinamide)                              20 mg 100%
Vitamin B6 (as pyridoxine Hcl)                     10 mg 500%
Folate                                                    1 mg 250%
Vitamin B12                                             6 mcg 100%
Biotin                                                     150 mcg 50%
Pantothenic acid (as calcium Pantothenate)  5 mg 50%

Other Ingredients: Glycerin, Gelatin, Lecithin, Soybean Oil, Starch, Yellow Beeswax, Titanium Dioxide, Yellow #6, Red #40, Blue #1

DIRECTIONS: One soft gel daily or as directed by a physician.

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

PRECAUTIONS: Folic acid may mask the symptoms of pernicious anemia in that hematologic remission may occur while neurological manifestations progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and paternal administration of folic acid.

STORAGE: Store at controlled room temperature 15-30o C (59-86o F). Keep container tightly closed and protect from heat and moisture.

Tamper evident by foil seal under cap. Do not use if foil cap is broken or missing.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

Manufactured for: Nnodum Pharmaceuticals
Cincinnati, OH 45240

Package Label Principal Display Panel

62044-622-90

Reno Caps

Dietary Supplementimage descriptionReno Cap 90ct

Nnodum
Pharmaceuticals

90 Softgels

Manufactured for: Nnodum Pharmaceuticals
Cincinnati, OH 45240

Package Label Principal Display Panel

Reno Caps 100-Count Bottle

62044-622-01

Reno Caps

Dietary Supplement

Nnodum
Pharmaceuticals

100 Softgels

Manufactured for: Nnodum Pharmaceuticals
Cincinnati, OH 45240

INGREDIENTS AND APPEARANCE

RENO CAPS  
reno caps capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:63044-622
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.7 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	20 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	150 ug
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	5 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	6 ug

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SOYBEAN OIL (UNII: 241ATL177A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:63044-622-01	100 in 1 BOTTLE
2	NHRIC:63044-622-90	90 in 1 BOTTLE
3	NHRIC:63044-622-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		03/01/2018

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
shape
size (solid drugs)	7 mm
scoring	1

Labeler - Nnodum Pharmaceuticals (960457273)

Registrant - Nnodum Pharmaceuticals (960457273)

Establishment
Name	Address	ID/FEI	Business Operations
Nnodum Pharmaceuticals		960457273	ANALYSIS(63044-622) , MANUFACTURE(63044-622)