Ferrous Sulfate Tablets 325 Mg (5 Gr)

Ferrous Sulfate Tablets 325 Mg (5 Gr)
SPL v3
SPL
SPL Set ID 5514d582-19b5-4f1e-b794-f790afb8211c
Route
ORAL
Published
Effective Date 2013-05-14
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 2008-11-05

Description

SAVE CARTON FOR COMPLETE PRODUCT INFORMATION Supplement Facts % Daily Value Iron (as ferrous sulfate) 65 mg 360%


Medication Information

Recent Major Changes

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.

Indications and Usage

SUGGESTED USE: 

Dosage and Administration

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.

Description

SAVE CARTON FOR COMPLETE PRODUCT INFORMATION Supplement Facts % Daily Value Iron (as ferrous sulfate) 65 mg 360%

Section 42229-5

SAVE CARTON FOR COMPLETE PRODUCT INFORMATION

Supplement Facts
% Daily Value
Iron (as ferrous sulfate) 65 mg 360%
Section 50565-1

OTHER INFORMATION:

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.

Section 53413-1

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

CR1210

Principle Display Panel

NDC 54738-963-13

Compare to Active Ingredient in Feosol ®*

Ferrous Sulfate Tablets

325 mg (5 gr)

Red

Iron Supplement

100 Tablets (25x4) UNIT DOSE

Richmond Pharmaceuticals, Inc.

Richmond, VA 23233

Section 55105-1

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

Children:As directed by the doctor.

Section 55106-9

EACH TABLET CONTAINS:                                                                 % U.S. RDA*

Elemental Iron 65 mg (Equivalent to 325 mg of Ferrous Sulfate)                        60

*U.S. Recommended Daily Allowance

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. 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.

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

Package Label.principal Display Panel

Structured Label Content

Recent Major Changes (34066-1)

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.

Indications and Usage (34067-9)

SUGGESTED USE: 

Dosage and Administration (34068-7)

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.

Section 42229-5 (42229-5)

SAVE CARTON FOR COMPLETE PRODUCT INFORMATION

Supplement Facts
% Daily Value
Iron (as ferrous sulfate) 65 mg 360%
Section 50565-1 (50565-1)

OTHER INFORMATION:

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.

Section 53413-1 (53413-1)

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

CR1210

Principle Display Panel

NDC 54738-963-13

Compare to Active Ingredient in Feosol ®*

Ferrous Sulfate Tablets

325 mg (5 gr)

Red

Iron Supplement

100 Tablets (25x4) UNIT DOSE

Richmond Pharmaceuticals, Inc.

Richmond, VA 23233

Section 55105-1 (55105-1)

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

Children:As directed by the doctor.

Section 55106-9 (55106-9)

EACH TABLET CONTAINS:                                                                 % U.S. RDA*

Elemental Iron 65 mg (Equivalent to 325 mg of Ferrous Sulfate)                        60

*U.S. Recommended Daily Allowance

Warnings: (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. 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.

Inactive Ingredients: (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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)