Ferrous Sulfate: Package Insert and Label Information

FERROUS SULFATE- ferrous sulfate tablet, film coated
Pharbest Pharmaceuticals, Inc.

Serving Size 1 Tablet

Servings Per Container 1000

Amount Per Serving % Daily Value
Iron (as ferrous sulfate) 65 mg 361%

Other ingredients: croscarmellose sodium, dicalcium phosphate, FD&C red #40, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Formula: Each tablet contains 202 mg of dried ferrous sulfate USP, equivalent to 325 mg of ferrous sulfate USP (65 mg of elemental iron), equivalent to 325 mg of ferrous sulfate USP.

Directions:

Adults and children over 12 years age: 1 tablet daily preferably with a meal or as directed by a doctor. Children under 12 years of age: consult a doctor. Do not exceed recommended dosage.

Caution:

Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within two hours of each other. If you are pregnant, nursing or taking any medications, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur.

WARNING: ´╗┐Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of overdose, call a doctor or Poison Control Center right immediately.

Store at room temperature. Keep tightly closed in a cool dry place.

Questions or comments? (866) 562-2756

PHARBEST

Manufactured in the USA

*Compare to the active ingredient in Feosol®

Ferrous

Sulfate

Iron Supplement

325 mg

1000 TABLETS

Ferrous Sulfate 325 mg Tablet Product Label
(click image for full-size original)

FERROUS SULFATE
ferrous sulfate 325 mg red tablet, film coated
Product Information
Product Type Item Code (Source) NDC:16103-359
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
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color red Score no score
Shape ROUND Size 10mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16103-359-08 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:16103-359-11 1000 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 07/22/2019
Labeler — Pharbest Pharmaceuticals, Inc. (557054835)
Registrant — Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
Name Address ID/FEI Operations
Pharbest Pharmaceuticals, Inc. 557054835 manufacture, analysis, pack, label

Revised: 03/2021 Pharbest Pharmaceuticals, Inc.

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