Label: FERROUS SULFATE tablet, coated
- NHRIC Code(s): 10135-161-01
- Packager: Marlex Pharmaceuticals Inc
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated February 15, 2019
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- Official Label (Printer Friendly)
- Supplement Facts
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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.
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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.
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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
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INGREDIENTS AND APPEARANCE
FERROUS SULFATE
ferrous sulfate tablet, coatedProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:10135-161 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 325 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:10135-161-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 02/01/2019 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 10 mm Labeler - Marlex Pharmaceuticals Inc (782540215)
