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Ferrous Sulfate Tablets Prescribing Information

Package insert / product label
Dosage form: tablet
Drug class: Iron products

Medically reviewed by Drugs.com. Last updated on Mar 27, 2023.

BOXED WARNING

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.

Ferrous Sulfate Tablets Description

Supplement Facts

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.

Ferrous Sulfate Tablets 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.

How is Ferrous Sulfate Tablets 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.

Manufactured for:
Boca Pharmacal, LLC
Coral Springs, FL 33065
www.bocapharmacal.com
1-800-354-8460
Rev. 09/13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ferrous Sulfate Tablets, USP 325mg

1000ct

NDC: 64376-809-10

a751fe4b-figure-01

[Rev. 10]

FERROUS SULFATE
iron tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64376-809
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64376-809-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/14/201006/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER09/14/201006/30/2018
Labeler - Boca Pharmacal, LLC (170266089)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835MANUFACTURE(64376-809)

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