Ferrous Sulfate: Package Insert and Label Information

FERROUS SULFATE- ferrous sulfate tablet, film coated
Marlex Pharmaceuticals Inc

Supplement Facts

Serving Size: 1 Tablet

Amount per Tablet % Daily Value

Iron (as dried ferrous sulfate) 65mg 361%

Active Ingredient (in each tablet) Purpose

Ferrous Sulfate Dietary Supplement

Warning:

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:

1 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:

Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C Blue #1, FD& C Yellow # 6, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol 400, Titanium Dioxide, Vegetable Magnesium Stearate, Vegetable Stearic Acid

Other Information:

  • Store in a cool, dry place at controlled room temperature 15-30ºC (59-86ºF)
  • Protect from moisture
  • Store in original container for better identification
  • Use by expiration date on package

Contains the following:

  • Sodium: 0.83mg per tablet
  • Calcium: 11.04mg per tablet
  • Magnesium: 0.21mg per tablet
  • Potassium: 0.006mg per tablet

M anufactured for/Distributed by:

Marlex Pharmaceuticals, Inc.,
New Castle, DE 19720

Rev. 1/20 HP

PRINCIPAL DISPLAY PANEL

NDC 10135- 0690-01
Ferrous Sulfate
Film-Coated Tablets
325 mg

100 Tablets

PRINCIPAL DISPLAY PANEL
NDC 10135-0690-01
Ferrous Sulfate 
Film-Coated Tablets
325 mg
100 Tablets
(click image for full-size original)
FERROUS SULFATE
ferrous sulfate tablet, film coated
Product Information
Product Type Item Code (Source) NDC:10135-690
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS SULFATE (FERROUS CATION) FERROUS CATION 65 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
STEARIC ACID
MAGNESIUM STEARATE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
MINERAL OIL
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-690-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 03/01/2020
Labeler — Marlex Pharmaceuticals Inc (782540215)

Revised: 03/2020 Marlex Pharmaceuticals Inc

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