FERROUS SULFATE- ferrous sulfate tablet, coated 
Marlex Pharmaceuticals Inc

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Ferrous Sulfate

Supplement Facts

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

Ferrous Sulfate Enteric-Coated Tablets Iron Supplement

Warnings

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 advice of a health professional before using this product.

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.

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.

Inactive 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.

Other Information:

• Store in a cool, dry place at controlled room temperature

15-30ºC (58-86ºF)

• Protect from moisture

• Store in original container for better identification

• Use by expiration date on package

• Tablets are enteric-coated to help protect your stomach.

Contains the following:

• Sodium: 0.83mg per tablet

• Calcium: 11.04mg per tablet

• Magnesium: 0.21mg per tablet

• Potassium 0.006mg per tablet

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

PRINCIPAL DISPLAY PANEL

NDC 10135-0161-01
Ferrous Sulfate
Enteric-Coated Tablets
Dietary
Supplement
325 mg

100 TABLETS

PRINCIPAL DISPLAY PANEL
NDC 10135-0161-01
Ferrous Sulfate 
Enteric-Coated Tablets 
Dietary Supplement
325 mg
100 TABLETS

FERROUS SULFATE 
ferrous sulfate tablet, coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:10135-161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION325 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
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)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:10135-161-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT02/01/2019
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)10 mm
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 2/2019
Document Id: 0d2e06de-1dcc-4848-9793-3129a5368957
Set id: dae4d4d1-e431-427b-b31f-57a5462fa9a1
Version: 1
Effective Time: 20190215
 
Marlex Pharmaceuticals Inc