FDA Label for Ferrous Sulfate
View Indications, Usage & Precautions
Ferrous Sulfate Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson Corporation Dba Sky Packaging. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Supplement Facts
| Serving Size: 1 teaspoonful (5 mL) |
| Amount Per Serving % DV* |
| Iron (elemental) 60 mg 33% |
| *Percent Daily Values (DV) are based on a 2,000 calorie diet. |
Ingredients
Ferrous Sulfate USP 300 mg (60 mg elemental iron) per 5 mL, citric acid, flavoring, purified water, sodium benzoate, sodium citrate, and sucrose.
Directions
As directed by a doctor or as follows:
Prevention of iron deficiency
Adults: 5 mL (1 teaspoonful) daily
Children under 12 years of age: consult a doctor
Iron replacement therapy in deficiency states
Adults: 5 mL (1 teaspoonful) 2 to 4 times daily preferably between meals.
Children under 12 years of age: consult a doctor
Mix 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,
Do not use:
- if you are taking other supplements containing iron
- for more than six months unless directed by your doctor
- may interfere with absorption of certain oral antibiotics (e.g., tetracycline) and other medications. These products should be taken within two (2) hours of each other.
- may cause occasional bowl effects such as constipation or diarrhea
Consult a doctor before use if you are pregnant or nursing.
Oral iron supplements:
Do Not Use
- if you are taking other supplements containing iron
- for more than six months unless directed by your doctor
- may interfere with absorption of certain oral antibiotics (e.g., tetracycline) and other medications. These products should be taken within two (2) hours of each other.
- may cause occasional bowl effects such as constipation or diarrhea
Consult a doctor before use if you are pregnant or nursing.
Oral iron supplements:
Warnings
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 and by beginning with one teaspoonful the first day, two the second, etc., until the recommended dosage is reached. Ferrous Sulfate Oral Solution may cause temporary staining of the teeth. This is less likely when the product is diluted. 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.
How Supplied
Yellow colored, cinnamon flavored oral solution supplied in the following oral dosage form:
Product Code 63739-157-70: 5 mL Unit Dose Cup
Product Code 63739-157-10: Case of 100, 5 mL Unit Dose Cups
Storage
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]
Protect from freezing. Protect from light.
Questions or comments? Call 1-800-845-8210. You may also report serious side effects to this phone number. Call your doctor for medical advice about side effects.
Distrbuted By:
McKesson Corporation
dba SKY Packaging
Memphis, TN 38141
Iss. 03/2022
Principal Display Panel
63739-157-70
Delivers 5 mL
Ferrous Sulfate Oral Solution USP
300 mg/5 mL
(Equivalent to approximately 60 mg elemental iron)
* Please review the disclaimer below.
