Ferrous Sulfate Tablets

Pronunciation

Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Ferrous Sulfate Tablets, USP

Ferrous Sulfate Tablets Description

Supplement Facts

Serving Size: 1 Tablet
Amount Per Tablet % Daily Value
Iron 65 mg 361 %

Other ingredients: Calcium phosphate, cellulose, croscarmellose sodium, FD&C red #40, hypromellose, magnesium stearate, mineral oil, polyethylene glycol, sodium starch glycolate, stearic acid (veg. grade), talc, and titanium dioxide.

Formula: Each tablet contains 200 mg of dried ferrous sulfate USP (65 mg of elemental iron), equivalent to 325 mg of ferrous sulfate USP.

Ferrous Sulfate Tablets Dosage and Administration

Directions: Adults and children over 12 years of age: 1 tablet daily as a dietary supplement, preferably with a meal or as directed by a doctor. Do not exceed 2 tablets in 24 hours. Not for frequent or prolonged use except on the advice of a doctor. Do not give to children under 12 years of age. 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.

How is Ferrous Sulfate Tablets Supplied

Storage and Handling

STORE AT 20°- 25°C (68° - 77°F); Excursions permitted to 15°- 30°C (59° - 86°F), see USP Controlled Room Temperature. Store away from heat and moisture. Keep tightly closed.

Tamper resistant: Do not use if seal under cap is broken or missing.

Manufactured for:
Boca Pharmacal, LLC
Coral Springs, FL 33065
www.bocapharmacal.com
1-800-354-8460
Rev. 09/13

BOXED WARNING

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 accidental overdose, call a doctor or poison control center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ferrous Sulfate Tablets, USP 325mg

1000ct

NDC: 64376-809-10

[Rev. 10]

FERROUS SULFATE 
iron tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64376-809
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
TALC  
TITANIUM DIOXIDE  
HYPROMELLOSES  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
MINERAL OIL  
CALCIUM PHOSPHATE  
CROSCARMELLOSE SODIUM  
FD&C RED NO. 40  
POWDERED CELLULOSE  
STEARIC ACID  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color RED Score no score
Shape ROUND Size 10mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:64376-809-10 1000 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/14/2010
Labeler - Boca Pharmacal, LLC (170266089)
Registrant - Boca Pharmacal, LLC (170266089)
Revised: 09/2013
 
Boca Pharmacal, LLC



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