FERROUS SULFATE- ferrous sulfate tablet, film coated 
RedPharm Drug, Inc.

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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ACTIVE INGREDIENT(S)

EACH TABLET CONTAINS:

Amount per tablet Iron 65 mg

% Daily Value 361%

Dried Ferrous Sulfate, equivalent to 325 mg Ferrous Sulfate per tablet.

INACTIVE INGREDIENT SECTIONS

Other ingredients for Red Tablets: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, sodium starch glycolate, hypromellose, stearic acid, polyethylene glycol (PEG) 400, FD&C red #40 aluminum lake, magnesium stearate, titanium dioxide, polyethylene glycol (PEG) 8000, carnauba wax

Other ingredients for Green Tablets: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, sodium starch glycolate, hypromellose, stearic acid, polyethylene glycol (PEG) 400, magnesium stearate, riboflavin, FD&C bule #1 aluminum lake, titanium dioxide, FD&C blue #2 aluminum lake, polyethylene glycol (PEG) 8000, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, carnauba wax

PURPOSE

Dietary Supplement

USE(S)

One tablet daily or as directed by a physician. For children under 12, consult a physician before using this product.

WARNINGS

Iron may interfere with absorpiton of certain antibiotics; these products should not be taken within two hours of each other.

Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking iron with meals. Iron-containing products may occassionally cause constipation or diarrhea. If pregnant or nursing consult a physicial before using this product.

DO NOT USE

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING

OTHER REQUIRED WARNINGS

The information on this label has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, trea, cure or prevent any disease.

To report a serious adverse event or to obtain product information, contact 800-818-4555.

KEEP OUT OF REACH OF CHILDREN

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.

DIRECTIONS

One tablet daily or as directed by a physician. For children under 12, consult a physical before using this product.

Do not exceed recommended dosage.

Do not use except under the advice and supervision of a physician.

STORAGE

Store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)

PACKAGE LABEL

FERROUS SULFATE

FERROUS SULFATE 
ferrous sulfate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1555(NDC:57664-070)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION325 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
RIBOFLAVIN (UNII: TLM2976OFR)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorgreenScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67296-1555-330 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
2NDC:67296-1555-660 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2018
Labeler - RedPharm Drug, Inc. (828374897)
Establishment
NameAddressID/FEIBusiness Operations
RedPharm Drug, Inc.828374897repack(67296-1555) , relabel(67296-1555)

Revised: 1/2020
Document Id: 9c9f9120-2ba5-48ce-e053-2995a90a0b76
Set id: 6806aeb1-8f2e-af84-e053-2991aa0a0c7b
Version: 3
Effective Time: 20200120
 
RedPharm Drug, Inc.