Ferrous Sulfate Tablets 325 Mg

Ferrous Sulfate Tablets 325 Mg
SPL v4
SPL
SPL Set ID 58dd4f30-980b-44bc-9f8e-8d4626854b91
Route
ORAL
Published
Effective Date 2017-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ferrous Cation (325 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: round Color: red Size: 8 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-06-01

Description

Serving Size: 1 Tablet Amount per Tablet % Daily Value  Iron (as ferrous sulfate)  65 mg  360 %

Purpose

Iron Supplement

Dosage and Administration

Each tablet contains: Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture.


Medication Information

Purpose

Iron Supplement

Dosage and Administration

Each tablet contains:Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture.

Description

Serving Size: 1 Tablet Amount per Tablet % Daily Value  Iron (as ferrous sulfate)  65 mg  360 %

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.

WARNINGS: Do not exceed recommended dosage.The treatment of any anemic condition should be under the advice and supervision of 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 baby, seek the advice of a health professional before using this product.   

Package Label

FERROUS SULFATE TABLETS 325 mg (5 gr)

Iron Supplement

NDC: 54738-963-01 – 100 Tablets 

NDC: 54738-963-03 – 1000 TABLETS

Suggested Use

Adults:One (1) tablet daily, preferably after meals or as directed by the doctor. Children:As directed by the doctor.

Active Ingredient

EACH TABLET CONTAINS:                  %U.S. RDA*

Elemental Iron 65 mg     360

(Equivalent to 325 mg of Ferrous Sulfate)

* U.S. Recommended Daily Allowance  

Inactive Ingredients

Croscarmellose sodium, dicalcium phosphate, FD&C RED#40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide

Supplement Facts[/s]
Serving Size: 1 Tablet

Amount per Tablet
% Daily Value
 Iron (as ferrous sulfate)  65 mg  360 %
Questions Or Comments

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP  IS MISSING OR DAMAGED

Call 804-270-4498 Monday-Friday, 8.30 am – 4.30 pm ET

Drug Interaction Precaution

Since oral iron products interfere with absorption of oral tetracycline antibiotics , these products should not be taken within two hours of each other.


Structured Label Content

Purpose

Iron Supplement

Warning: (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.

WARNINGS: Do not exceed recommended dosage.The treatment of any anemic condition should be under the advice and supervision of 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 baby, seek the advice of a health professional before using this product.   

Package Label

FERROUS SULFATE TABLETS 325 mg (5 gr)

Iron Supplement

NDC: 54738-963-01 – 100 Tablets 

NDC: 54738-963-03 – 1000 TABLETS

Suggested Use (SUGGESTED USE)

Adults:One (1) tablet daily, preferably after meals or as directed by the doctor. Children:As directed by the doctor.

Active Ingredient

EACH TABLET CONTAINS:                  %U.S. RDA*

Elemental Iron 65 mg     360

(Equivalent to 325 mg of Ferrous Sulfate)

* U.S. Recommended Daily Allowance  

Inactive Ingredients

Croscarmellose sodium, dicalcium phosphate, FD&C RED#40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide

Supplement Facts[/s] (Supplement Facts[/S])
Serving Size: 1 Tablet

Amount per Tablet
% Daily Value
 Iron (as ferrous sulfate)  65 mg  360 %
Questions Or Comments (Questions or Comments)

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP  IS MISSING OR DAMAGED

Call 804-270-4498 Monday-Friday, 8.30 am – 4.30 pm ET

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Each tablet contains:Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture.

Drug Interaction Precaution (DRUG INTERACTION PRECAUTION)

Since oral iron products interfere with absorption of oral tetracycline antibiotics , these products should not be taken within two hours of each other.


Advanced Ingredient Data


Raw Label Data

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