FERROUS SULFATE  - ferrous sulfate tablet 
Unit Dose Services

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 325 mg (5 gr)

Supplement Facts[/S]

Serving Size: 1 Tablet
Amount per Tablet
% Daily Value
Iron (as ferrous sulfate)  65 mg360 %

SUGGESTED USE

One (1) tablet daily, preferably after meals or as directed by the doctor. As directed by the doctor. Adults:Children:

Active Ingredient

U.S. RDA* EACH TABLET CONTAINS:                  %

Elemental Iron 65 mg     360

(Equivalent to 325 mg of Ferrous Sulfate)

* U.S. Recommended Daily Allowance  

Inactive Ingredients

Croscarmellose sodium, dicalcium phosphate, FD&C RED#40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide

Purpose

Iron Supplement

WARNING:

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. . In case of accidental overdose, call a doctor or Poison Control Center immediately. Keep this product out of reach of children

The treatment of any anemic condition should be under the advice and supervision of doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea. WARNINGS: Do not exceed recommended dosage.

As with any drug, if you are pregnant or nursing baby, seek the advice of a health professional before using this product.   

DRUG INTERACTION PRECAUTION

Since oral iron products interfere with absorption of oral tetracycline antibiotics , these products should not be taken within two hours of each other.

DOSAGE AND ADMINISTRATION

Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture. Each tablet contains:

Questions or Comments

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS BROKEN OR DAMAGED

Distributed by: Qualitest Pharmaceuticals, Inc.

FERROUS SULFATE (IRON SUPPLEMENT) TABLET

Label Image
FERROUS SULFATE  
iron supplement tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50436-5891(NDC:0603-0179)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (FERROUS CATION) FERROUS CATION325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50436-5891-130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/19/2001
Labeler - Unit Dose Services (831995316)
Registrant - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIBusiness Operations
Unit Dose Services831995316REPACK(50436-5891)

Revised: 4/2013
Document Id: 847b2ae7-9473-42f3-bdf4-0aa1d59ceb85
Set id: 91ff2cb4-1fb9-4125-9435-c9d008161203
Version: 2
Effective Time: 20130412
 
Unit Dose Services