FERROUS SULFATE ENTERIC-COATED- ferrous sulfate tablet

Ferrous Sulfate by

Drug Labeling and Warnings

Ferrous Sulfate by is a Other medication manufactured, distributed, or labeled by Upsher-Smith Laboratories. LLC. 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: microcrystalline cellulose, dibasic calcium phosphate dihydrate, anhydrous lactose, hypromellose phthalate, croscarmellose sodium, stearic acid, magnesium stearate, triacetin, FD&C Red #40 aluminum lake, colloidal silicon dioxide, titanium dioxide, hypromellose, mineral oil.

Contains: Milk

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

Store in a cool, dry place. Protect contents from light and moisture.

Caution

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 products may cause constipation or diarrhea. As with any dietary supplement, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

WARNINGS

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.

HEALTH CLAIM

DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN, OR MISSING.

Questions or comments?

1-800-650-3789 Mon–Fri 8am to 5pm CST

HEALTH CLAIM

Distributed by
UPSHER-SMITH LABORATORIES, LLC
Maple Grove, MN 55369

© 2024 Upsher-Smith Laboratories, LLC

CC8-02450108-11
133R R0324

PRINCIPAL DISPLAY PANEL - 325 mg Blister Pack Label

List 0245-0108-11

Ferrous Sulfate
Enteric-Coated
Tablets

Dietary Supplement

325 mg

100 Tablets

UPSHER-SMITH

INGREDIENTS AND APPEARANCE

FERROUS SULFATE  ENTERIC-COATED
ferrous sulfate tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:0245-0108
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)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:0245-0108-11	100 in 1 BOTTLE
2	NHRIC:0245-0108-10	1000 in 1 BOTTLE
3	NHRIC:0245-0108-01	4 in 1 CARTON
3	NHRIC:0245-0108-89	25 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		07/22/2002

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

Labeler - Upsher-Smith Laboratories. LLC (079111820)