Label: FERROUS SULFATE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-308-01 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 57664-071
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated March 22, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
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INACTIVE INGREDIENTS
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
- USE(S)
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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
- OTHER REQUIRED WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- STORAGE
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PRINCIPAL DISPLAY PANEL - 325 MG Tablet Bottle Label
CommUnityCare Federally Qualified Health Centers
FERROUS
SULFATE
325MG #
100Date:
Name:
Dr.TAKE 1 TABLET 1 TO 3 TIMES PER DAY WITH FOOD, AS
DIRECTED.123456
1/1/01
FERROUS SULF 325MG TABS# 100 NDC 76413-308-01
Batch: 123456
Lot: 123456
Exp: 1/1/01
SUN PHARMAFederal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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INGREDIENTS AND APPEARANCE
FERROUS SULFATE
ferrous sulfate tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-308(NDC:57664-071) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 325 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) HYPROMELLOSES (UNII: 3NXW29V3WO) STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) CARNAUBA WAX (UNII: R12CBM0EIZ) Product Characteristics Color RED Score no score Shape ROUND Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-308-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 07/01/2014 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-308) , RELABEL(76413-308)