FERROUS SULFATE - ferrous sulfate tablet 
Boca Pharmacal, LLC

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.

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Ferrous Sulfate Tablets, USP

DESCRIPTION

Supplement Facts

Serving Size: 1 Tablet
Amount Per Tablet% Daily Value
Iron 65 mg361 %

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.

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 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

a751fe4b-figure-01

[Rev. 10]

FERROUS SULFATE 
iron tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64376-809
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (FERROUS CATION) FERROUS CATION65 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64376-809-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/14/2010
Labeler - Boca Pharmacal, LLC (170266089)
Registrant - Boca Pharmacal, LLC (170266089)

Revised: 9/2013
Document Id: a751fe4b-9ac3-4548-b33f-eb2205537447
Set id: 444b2413-b539-4dff-af7f-ef00a56f7c2b
Version: 2
Effective Time: 20130918
 
Boca Pharmacal, LLC