Ferrous Sulfate by Richmond Pharmaceuticals Inc. / Advance Pharmaceutical Inc. FERROUS SULFATE tablet

Ferrous Sulfate by

Drug Labeling and Warnings

Ferrous Sulfate by is a Otc medication manufactured, distributed, or labeled by Richmond Pharmaceuticals Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SAVE CARTON FOR COMPLETE PRODUCT INFORMATION

• Iron (as ferrous sulfate) 65 mg: 360%

SUGGESTED USE: 

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

Children: As directed by the doctor.

EACH TABLET CONTAINS:                                                                  % U.S. RDA*

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

*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

BOXED WARNING

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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 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.

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.

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.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FERROUS SULFATE 
ferrous sulfate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54738-963
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	325 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54738-963-13	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/05/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/05/2008

Labeler - Richmond Pharmaceuticals Inc. (043569607)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc.		078301063	manufacture(54738-963)