Label: FOLITAB- vitamin c, folate, iron tablet
- NHRIC Code(s): 64980-173-98, 64980-173-03
- Packager: Rising Pharma Holdings, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated June 21, 2025
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- STATEMENT OF IDENTITY
- HEALTH CLAIM
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WARNINGS
CONTRAINDICATIONS:
Contraindicated in patients with pernicious anemia and in the rare instance of hypersensitivity to folic acid. Hemochromatosis and hemosiderosis are contraindications to iron therapy.WARNING:
Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B-12 is deficient.
Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other.
Iron-containing supplements may occasionally cause bowel effects such as constipation.
- DOSAGE & ADMINISTRATION
- PRECAUTIONS:
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STORAGE:
Store below 77°F (25°C). Protect from light to avoid tablet color changes.
Keep this carton for complete product information.
DISTRIBUTED BY: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816
This address is to be used for reporting adverse events associated with the use of this product.
Questions? Call 1-844-474-7464
FT02
Revised: 06/2025
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FOLITAB
vitamin c, folate, iron tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:64980-173 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 500 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1360 ug IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 105 mg Inactive Ingredients Ingredient Name Strength Microcrystalline Cellulose (UNII: OP1R32D61U) Stearic Acid (UNII: 4ELV7Z65AP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) COPOVIDONE K25-31 (UNII: D9C330MD8B) Croscarmellose Sodium (UNII: M28OL1HH48) Magnesium Stearate (UNII: 70097M6I30) Dicalcium Phosphate (UNII: L11K75P92J) Polyethylene Glycol (UNII: 3WJQ0SDW1A) Mineral Oil (UNII: T5L8T28FGP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Titanium Dioxide (UNII: 15FIX9V2JP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:64980-173-98 10 in 1 BLISTER PACK 1 NHRIC:64980-173-03 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 07/11/2011 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 19 mm scoring 1 Labeler - Rising Pharma Holdings, Inc. (116880195)



