FERROUS SULFATE- iron supplement therapy tablet

Ferrous Sulfate by

Drug Labeling and Warnings

Ferrous Sulfate by is a Prescription medication manufactured, distributed, or labeled by Healthlife of USA, Advance Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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 therapy325mg each tablet30 Tablets 

INGREDIENTS AND APPEARANCE

FERROUS SULFATE 
iron supplement therapy tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69517-133
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	65 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-133-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/05/2017

Labeler - Healthlife of USA (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceuticals		078301063	manufacture(69517-133)