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FERROUS SULFATE by Richmond Pharmaceuticals, Inc.

Medically reviewed on October 30, 2017

Dosage form: tablet
Ingredients: FERROUS SULFATE 325mg
Labeler: Richmond Pharmaceuticals, Inc.
NDC Code: 54738-963

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 325 mg

Supplement Facts[/S]
Serving Size: 1 Tablet
Amount per Tablet
% Daily Value
 Iron (as ferrous sulfate)  65 mg  360 %

SUGGESTED USE

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

Active Ingredient

EACH TABLET CONTAINS:                  % U.S. RDA*

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. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

WARNINGS: Do not exceed recommended dosage. 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.

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

Each tablet contains: 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.

Questions or Comments

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP  IS MISSING OR DAMAGED

Call 804-270-4498 Monday-Friday, 8.30 am – 4.30 pm ET

Package Label

FERROUS SULFATE TABLETS 325 mg (5 gr)

Iron Supplement

NDC: 54738-963-01 – 100 Tablets 

NDC: 54738-963-03 – 1000 TABLETS

FERROUS SULFATE 
ferrous sulfate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-963
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 
DIBASIC CALCIUM PHOSPHATE 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 Description
1NDC:54738-963-01100 TABLET in 1 BOTTLE
2NDC:54738-963-031000 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2015
Labeler - Richmond Pharmaceuticals, Inc. (043569607)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063manufacture(54738-963)

 
Richmond Pharmaceuticals, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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