Ferrous sulfate tablet, film coated

Active ingredient(s)

EACH TABLET CONTAINS:

Dried Ferrous Sulfate, equivalent to 325 mg Ferrous Sulfate per tablet.

Amount per tablet

% Daily Value

Iron 65 mg

361%

Inactive ingredients

Other ingredients for Red Tablets:microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, sodium starch glycolate, hypromellose, stearic acid, polyethylene glycol (PEG) 400, FD&C red #40 aluminum lake, magnesium stearate, titanium dioxide, polyethylene glycol (PEG) 8000, carnauba wax

Other ingredients forGreen Tablets:microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, sodium starch glycolate, hypromellose, stearic acid, polyethylene glycol (PEG) 400, magnesium stearate, riboflavin, FD&C bule #1 aluminum lake, titanium dioxide, FD&C blue #2 aluminum lake, polyethylene glycol (PEG) 8000, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, carnauba wax

Purpose

Dietary Supplement

Use(s)

One tablet daily or as directed by a physician. For children under 12, consult a physician before using this product.

Warnings

Iron may interfere with absorpiton of certain antibiotics; these products should not be taken within two hours of each other.

Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking iron with meals. Iron-containing products may occassionally cause constipation or diarrhea. If pregnant or nursing consult a physicial before using this product.

Do not use

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

Other required warnings

The information on this label has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, trea, cure or prevent any disease.

To report a serious adverse event or to obtain product information, contact 800-818-4555.

Keep out of reach of children

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

One tablet daily or as directed by a physician. For children under 12, consult a physical before using this product.

Do not exceed recommended dosage.

Do not use except under the advice and supervision of a physician.

Storage

Store at 25C (77F); excursions permitted between 15-30C (59-86F)

Ingredients and appearance - Product information

Ferrous sulfate tablet, film coated- Ferrous sulfate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68788-6964
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ferrous sulfate ( UNII: 39R4TAN1VT)( Ferrous cation - UNII: GW89581OWR ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Microcrystalline cellulose ( UNII: OP1R32D61U)
Dibasic calcium phosphate dihydrate ( UNII: O7TSZ97GEP)
Croscarmellose sodium ( UNII: M28OL1HH48)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Stearic acid ( UNII: 4ELV7Z65AP)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Magnesium stearate ( UNII: 70097M6I30)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycol 8000 ( UNII: Q662QK8M3B)
Carnauba wax ( UNII: R12CBM0EIZ)

Product Characteristics

Color RED Size 10 mm
Shape ROUND Score 1

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
Unapproved drug other USA

Labeler - Preferred Pharmaceuticals Inc.( 791119022)

Establishment

Name ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL( 68788-6964)

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