FERROUS SULFATE- iron supplement therapy tablet 
Healthlife of USA

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
Iron supplement therapy

Supplement Facts

Amount per serving

Iron (as dried ferrous sulfate) 65mg.............360%

Directions

Adults and children 12 years of age and over: Take one tablet daily, preferably after a meal, or as directed by a physician. Children under 12 years of age: consult a physician. Do not chew or crush tablet. Tablets are enteric-coated to  help protect your stomach.

Other Ingredients

Dicalcium phosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium stearate, silica, methacrylic acid copolymer, propylene glycol, talc, titanium dioxide, polysorbate, sodium lauryl sulfate, polyvinyl alcohol, FD&C Red #40.

Warnings

Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Iron-containing products may cause constipation or diarrhea. As with any dietary supplement, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.

Boxed 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.

Storage

Store in a cool, dry place.

Protect contents from light and moisture. you may report side effects by calling 1-844-221-7294.

Ferrous Sulfate 
Iron supplement therapy
325mg each tablet
30 Tablets 

image description

FERROUS SULFATE 
iron supplement therapy tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69517-133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorgreenScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69517-133-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/05/201712/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/05/201712/31/2021
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceuticals078301063manufacture(69517-133)

Revised: 6/2024
Document Id: 085ae7cd-f17d-e74a-e063-6394a90a9f9e
Set id: 38104333-f334-4d97-8657-94a00942faf2
Version: 2
Effective Time: 20240613
 
Healthlife of USA