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 Central Texas Community Health Centers. 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.
Active Ingredient(S)
EACH TABLET CONTAINS:
| Dried Ferrous Sulfate, equivalent to 325 mg Ferrous Sulfate per tablet. | |
| Amount per tablet | % Daily Value |
| Iron 65 mg | 361% |
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
Dietary Supplement
Use(S)
One tablet daily or as directed by a physician. For children under 12, consult a physician before using this product.
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
TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING
Other Required Warnings
| The information on this label has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, trea, cure or prevent any disease. |
To report a serious adverse event or to obtain product information, contact 800-818-4555.
Keep Out Of Reach Of Children
| WARNING: 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. |
Directions
One tablet daily or as directed by a physician. For children under 12, consult a physical before using this product.
Do not exceed recommended dosage.
Do not use except under the advice and supervision of a physician.
Storage
Store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)
Principal Display Panel - 325 Mg Tablet Bottle Label
CommUnityCare Federally Qualified Health Centers
FERROUS
SULFATE
325MG #
100
Date:
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 PHARMA
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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