FERROUS SULFATE- iron supplement tablet

FERROUS SULFATE by

Drug Labeling and Warnings

FERROUS SULFATE by is a Otc medication manufactured, distributed, or labeled by Unit Dose Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Supplement Facts[/S]

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

SUGGESTED USE

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

Active Ingredient

U.S. RDA* EACH TABLET CONTAINS:                  %

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

Purpose

Iron Supplement

WARNING:

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. . In case of accidental overdose, call a doctor or Poison Control Center immediately. Keep this product out of reach of children

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. WARNINGS: Do not exceed recommended dosage.

As with any drug, if you are pregnant or nursing 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.

DOSAGE AND ADMINISTRATION

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. Each tablet contains:

Questions or Comments

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS BROKEN OR DAMAGED

Distributed by: Qualitest Pharmaceuticals, Inc.

FERROUS SULFATE (IRON SUPPLEMENT) TABLET

INGREDIENTS AND APPEARANCE

FERROUS SULFATE  
iron supplement tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50436-5890(NDC: 0603-0179)
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)
CALCIUM PHOSPHATE, DIBASIC, 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: 50436-5890-1	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		02/19/2001

Labeler - Unit Dose Services (831995316)

Registrant - Unit Dose Services (831995316)

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose Services		831995316	REPACK(50436-5890)