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

Enteric Coated Ferrous Sulfate by

Drug Labeling and Warnings

Enteric Coated Ferrous Sulfate by is a Other medication manufactured, distributed, or labeled by Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving	% Daily Value
Iron (as dried ferrous sulfate) 65 mg	361%

Other ingredients: carmine, croscarmellose sodium, dicalcium phosphate, hypromellose, isomalt, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, riboflavin, rice starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stearic acid, talc, triacetin, triglycerides

DOSAGE & ADMINISTRATION

Directions: Adults and children 12 years of age and over: Take one tablet daily, preferably after a meal, or as directed by a physician. Children under 12 years of age: Consult a physician. Do not chew or crush tablet.

Tablets are enteric-coated to help protect your stomach.

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. In case of accidental overdose, call a doctor or poison control center immediately (800-222-1222).

WARNINGS

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 medicine and vitamins with iron be packaged in child-resistant closures. Parents should always use properly re-secure safety closures.

SAFE HANDLING WARNING

Storage: Store at 20° - 25°C (68° - 77°F) (see USP Controlled Room Temperature)

HEALTH CLAIM

Questions or Comments? (866)562-2756 (Mon-Fri 8 AM to 4 PM EST)

HEALTH CLAIM

†This product is manufactured in a facility which shares manufacturing equipment used for manufacturing other product containing titanium dioxide.

HEALTH CLAIM

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

HEALTH CLAIM

Manufactured by:
Pharbest Pharmaceuticals, Inc. Farmingdale, NY 11735

Org. 05/25

More Supplement Facts

PRINCIPAL DISPLAY PANEL

PHARBEST

Manufactured in the USA

16103-414-08

Enteric Coated

Ferrous Sulfate

Iron Supplement

Titanium Dioxide Free†

324 mg

100 Tablets

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:16103-414
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
CARMINIC ACID (UNII: CID8Z8N95N)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ISOMALT (UNII: S870P55O2W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
RIBOFLAVIN (UNII: TLM2976OFR)
STARCH, RICE (UNII: 4DGK8B7I3S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:16103-414-08	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		06/17/2025

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	10 mm

Labeler - Pharbest Pharmaceuticals, Inc. (557054835)