FERROUS SULFATE 324MG ENTERIC COATED- ferrous sulfate tablet, delayed release

Ferrous Sulfate 324mg Enteric Coated by

Drug Labeling and Warnings

Ferrous Sulfate 324mg Enteric Coated by is a Other medication manufactured, distributed, or labeled by Nationwide Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

Ferrous Sulfate
Enteric-Coated Tablets
324mg
Dietary Supplement

CONTAINS

Each tablet contains 324 mg of ferrous sulfate, equivalent to 65 mg of elemental iron, providing 362% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

DIRECTIONS FOR USE

Do not crush or chew tablets. Adult Serving Size: 1 tablet two to three times daily. Children: Consult a physician.

SAFE HANDLING WARNING

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. Incase of accidental overdose, call a doctor or poison control center immediately.

WARNINGS

Do not take within 2 hours of taking oral tetracycline antibiotics, since oral iron products tend to interfere with absorption of tetracycline. May cause gastrointestinal discomfort, nausea, constipation or diarrhea. If you are pregnant or nursing a baby, seek advice of a health professional before using this product. U.S. Consumer Product Safety Commission requires that iron-containing medicines and vitamins with iron be packaged in child-resistant closures. Parents should always properly resecure safety closures.

STORAGE

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

STATEMENT OF IDENTITY

Supplement Facts Serving Size 1 Tablet
Amount Per Tablet		% Daily Value
Iron (as ferrous sulfate)	65 mg	362%

Other ingredients: Microcrystalline Cellulose, Dibasic Calcium Phosphate Dihydrate, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Triacetin, FD&C Red No. 40, Silicon Dioxide, Hypromellose, Methacrylic Acid, Mineral Oil

HEALTH CLAIM

Packaged For: Nationwide Pharmaceutical, LLC
San Antonio, Tx 78232 (4-20)

PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label

Nationwide
Pharmaceutical

NDC: 69375-0003-10

Ferrous Sulfate
Enteric-Coated Tablets

324mg
Dietary
Supplement

CONTAINS: Each tablet contains 324 mg of ferrous sulfate,
equivalent to 65 mg of elemental iron, providing 362% of
the U.S. recommended daily intake (RDI) of iron for adults
and children 4 and older.

DIRECTIONS FOR USE: Do not crush or chew tablets.
Adult Serving Size: 1 tablet two to three times daily.
Children: Consult a physician.

Net Contents 100 Tablets

INGREDIENTS AND APPEARANCE

FERROUS SULFATE 324MG ENTERIC COATED 
ferrous sulfate tablet, delayed release

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:69375-003
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TRIACETIN (UNII: XHX3C3X673)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69375-003-10	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		03/25/2020

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	2
shape
size (solid drugs)	11 mm
imprint

Labeler - Nationwide Pharmaceutical, LLC (079265801)