Label: FERROUS SULFATE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 67296-1555-3, 67296-1555-6 - Packager: RedPharm Drug, Inc.
- This is a repackaged label.
- Source NDC Code(s): 57664-070
- 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 January 20, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
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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
- 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
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
FERROUS SULFATE
ferrous sulfate tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67296-1555(NDC:57664-070) 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 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 Color green Score no score Shape ROUND Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67296-1555-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 2 NDC:67296-1555-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2018 Labeler - RedPharm Drug, Inc. (828374897) Establishment Name Address ID/FEI Business Operations RedPharm Drug, Inc. 828374897 repack(67296-1555) , relabel(67296-1555)
