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Ferrous Sulfate

Paddock Laboratories, LLC

FERROUS SULFATEENTERIC-COATED TABLETS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Dietary Supplement

CONTAINS:

Each tablet contains 324 mg of ferrous sulfate, equivalent to 65 mg of elemental iron, providing 362% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

DIRECTIONS FOR USE:

Do not crush or chew tablets. Adult Serving Size: 1 tablet two to three times daily. Children: Consult a physician.

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.

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 medicines and vitamins with iron be packaged in child-resistant closures. Parents should always properly resecure safety closures.

STORAGE:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Supplement Facts

Serving Size 1 Tablet
Amount Per Tablet % Daily Value
Iron (as ferrous sulfate) 65 mg 362%

Other ingredients: Corn Starch, Calcium Stearate, Powdered Cellulose, Lactose, Talc, Copovidone, Polyethylene Glycol, Maltodextrin, Sucrose, Povidone, Calcium Carbonate, Titanium Dioxide, Magnesium Stearate, Shellac, Cocoa Butter, FD&C Red No. 40 Aluminum Lake, Sodium Starch Glycolate A, Sodium Lauryl Sulfate, Colloidal Silicon Dioxide, Methacrylic Acid Copolymer Type C, Sodium Hydroxide, Simethicone Emulsion, Diethyl Phthalate, Hypromellose, Carnauba Wax, White Wax.

Packaged by: Paddock Laboratories, Inc.
Minneapolis, MN 55427

(01-08)

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 0574-0608-01
FERROUS SULFATE
ENTERIC-COATED TABLETS

324 mg

Dietary
Supplement

CONTAINS: Each tablet contains 324 mg
of ferrous sulfate, equivalent to 65 mg of
elemental iron, providing 362% of the U.S.
recommended daily intake (RDI) of iron for
adults and children 4 and older.

DIRECTIONS FOR USE: Do not crush or chew
tablets. Adult Serving Size: 1 tablet two to three
times daily. Children: Consult a physician.

NET CONTENTS 100 TABLETS

Paddock
Laboratories, Inc.

Ferrous Sulfate

Ferrous Sulfate

FERROUS SULFATE TABLET

Product Information

Product Type Dietary supplement Item Code (Source) NDC:0574-0608
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FERROUS SULFATE FERROUS CATION 324 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CALCIUM STEARATE
POWDERED CELLULOSE
LACTOSE
talc
COPOVIDONE K25-31
POLYETHYLENE GLYCOLS
maltodextrin
SUCROSE
povidone
CALCIUM CARBONATE
titanium dioxide
MAGNESIUM STEARATE
SHELLAC
COCOA BUTTER
FD&C RED NO. 40
SODIUM LAURYL SULFATE
SILICON DIOXIDE
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SODIUM HYDROXIDE
diethyl phthalate
HYPROMELLOSES
carnauba wax
white wax

Product Characteristics

Color Size Shape
RED 11 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0574-0608-01 100 in 1 BOTTLE
2 10 in 1 BLISTER PACK
3 NDC:0574-0608-10 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-08-06


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Be sure to consult your doctor before taking any medication!
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