Label: FERROUS SULFATE tablet
- NDC Code(s): 54738-963-13
- Packager: Richmond Pharmaceuticals Inc.
- 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.
Updated December 23, 2019
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- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENTS:
- BOXED WARNING (What is this?)
Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea.
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
QUESTIONS OR COMMENTS?
call 804-270-4498, 8:30 am - 4:30 pm ET, Monday – Friday
TAMPER EVIDENT: DO NOT USE IF A BLISTER PACKAGE UNIT IS TORN, BROKEN OR SHOW ANY SIGN OF TAMPERING
*Richmond Pharmaceuticals, Inc. is not affiliated with the owner of the registered trademark FEOSOL®.
Distributed by: Richmond Pharmaceuticals, Inc., Richmond, VA 23233, USA
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Compare to Active Ingredient in Feosol ®*
Ferrous Sulfate Tablets
325 mg (5 gr)
100 Tablets (25x4) UNIT DOSE
Richmond Pharmaceuticals, Inc.
Richmond, VA 23233
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ferrous sulfate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54738-963 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape ROUND Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54738-963-13 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/05/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/05/2008 Labeler - Richmond Pharmaceuticals Inc. (043569607) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(54738-963)