Label: FERROUS SULFATE solution
- NHRIC Code(s): 57237-311-51, 57237-311-05
- Packager: Rising Pharma Holdings, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated May 12, 2025
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- STATEMENT OF IDENTITY
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HEALTH CLAIM
Other ingredients: Purified water, sucrose, citric acid, sodium benzoate, and cinnamon flavor.
Use: Ferrous Sulfate Oral Solution is an iron supplement for the treatment and prevention of iron deficiency and iron deficient anemia when the need for such therapy has been determined by a healthcare professional.†
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Directions:
May be mixed with water or fruit juice and drink through a straw to avoid temporary staining of teeth. Do not mix with milk or wine based vehicles.
As directed by a doctor or as follows- Prevention of iron deficiency
Adults: 5mL (1 unit dose) daily
Children under 12 years of age: Consult of doctor - Iron replacement therapy in deficiency states
Adults: 5mL (1 unit dose) two (2) to four (4) times daily preferable between meals
Children under 12 years of age: Consult of doctor
- Prevention of iron deficiency
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SAFE HANDLING WARNING
Do not use
- If you are taking other iron containing supplements
- For more than six months unless directed by a doctor
Oral Iron Supplements
- May interfere with absorption of certain antibiotics (e.g. tetracycline and other medications). These products should not be taken with two (2) hours of each other.
- May cause occasional bowel effects such as constipation or diarrhea.
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WARNINGS
Warnings
Do not exceed recommended dosage: The treatment of anemic conditions should be under the advice and supervision of a doctor. Occasional gastrointestinal or discomfort (such as nausea) may be minimized by taking supplement between meals. Also in order to minimize gastrointestinal or discomfort, may begin by taking 5 mL (1 unit dose) and increase dosage over time. Staining of teeth may occur with ferrous sulfate oral solution.
Warning: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under six (6). Keep out of reach of children. In case of accidental overdose call a doctor or contact a Poison Control Center right away. (1-880-222-1222)
- PRECAUTIONS
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DOSAGE & ADMINISTRATION
Storage
• store at 20° to 25°C (68°to 77°F). [See USP Controlled Room Temperature]
• preserve in tight, light-resistant containers
• protect from freezing and light
• do not use if lid is torn or broken
Questions or comments? Call-1-844-474-7464
†This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
FG-27/Iss.:03/2023 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FERROUS SULFATE
ferrous sulfate solutionProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:57237-311 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 300 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:57237-311-51 100 in 1 BOX, UNIT-DOSE 1 NHRIC:57237-311-05 5 mL in 1 CUP, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 05/22/2023 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value flavor Labeler - Rising Pharma Holdings, Inc. (116880195)
