Label: FERROUS SULFATE- iron tablet
- NDC Code(s): 64376-809-10
- Packager: Boca Pharmacal, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated September 18, 2013
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- BOXED WARNING(What is this?)
Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.Close
Serving Size: 1 Tablet Amount Per Tablet % Daily Value Iron 65 mg 361 %
Other ingredients: Calcium phosphate, cellulose, croscarmellose sodium, FD&C red #40, hypromellose, magnesium stearate, mineral oil, polyethylene glycol, sodium starch glycolate, stearic acid (veg. grade), talc, and titanium dioxide.
Formula: Each tablet contains 200 mg of dried ferrous sulfate USP (65 mg of elemental iron), equivalent to 325 mg of ferrous sulfate USP.Close
- DOSAGE AND ADMINISTRATION
Directions: Adults and children over 12 years of age: 1 tablet daily as a dietary supplement, preferably with a meal or as directed by a doctor. Do not exceed 2 tablets in 24 hours. Not for frequent or prolonged use except on the advice of a doctor. Do not give to children under 12 years of age. Do not exceed recommended dosage.
Caution: Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within two hours of each other. If you are pregnant, nursing or taking any medications, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur.Close
- HOW SUPPLIED
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. Store away from heat and moisture. Keep tightly closed.
Tamper resistant: Do not use if seal under cap is broken or missing.
Boca Pharmacal, LLC
Coral Springs, FL 33065
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Ferrous Sulfate Tablets, USP 325mg
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64376-809 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 65 mg Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) MINERAL OIL (UNII: T5L8T28FGP) CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) POWDERED CELLULOSE (UNII: SMD1X3XO9M) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color RED Score no score Shape ROUND Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64376-809-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/14/2010 06/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 09/14/2010 06/30/2018 Labeler - Boca Pharmacal, LLC (170266089) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 MANUFACTURE(64376-809)