FERROUS SULFATE by Rij Pharmaceutical Corporation FERROUS SULFATE elixir

FERROUS SULFATE by

Drug Labeling and Warnings

FERROUS SULFATE by is a Otc medication manufactured, distributed, or labeled by Rij Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL) (one teaspoonful)

Ferrous Sulfate 220 mg (44 mg of elemental Iron)

Purpose

Iron Supplement

Uses

a therapy for simple iron deficiency and iron deficiency anemia

Warnings

Adverse Reactions:

occasional gastrointestinal discomfort such as nausea dose related bowel effects (such as constipation or diarrhea), gastrointestinal effects may be minimized by the administration with or immediately after meals and bowel effects reduced by giving the minimum effective dosage.

Do not use

• more than directed

The treatment of any anemic condition should be under the advice and supervision of a physician

Ask a doctor or pharmacist before use if you are

taking oral Tetracycline antibiotics. Oral iron products interfere with absorption of oral tetracycline antibiotics. These products should not be taken within two hours of each other.

When using this product

• may occasionally cause constipation or diarrhea
• may cause temporary staining of the teeth (this is less likely when diluted)

If pregnant or breast-feeding

ask a health professional before use.

Keep this and all drugs out of reach of children.

Contains iron, which can be harmful or fatal to children in large doses. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Treatment of overdose:

quickly induce vomiting, then feed eggs and milk until gastric lavage can be done. Lavage with 1 percent Sodium Bicarbonate and administer an iron chelating agent (such as deferoxamine mesylate) BAL should not be used. Gastric lavage should not be performed after the first hour because the danger of perforation due to gastric necrosis. Measures to combat shock, dehydration, blood loss and respiratory failure may be necessary.

Directions

Mix with water or fruit juice to avoid temporary staining of the teeth, do not mix with milk or wine-based vehicles

• Adults and children 12 years of age and over: 1 teaspoonful daily, or as directed by a physician
• Children under 12 years of age: Consult a physician

Inactive ingredients

citric acid, FD & C yellow #6, flavor, sodium benzoate, sucrose and water.

Other information

• Store in tight, light-resistant container at room temperature

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FERROUS SULFATE 
ferrous sulfate elixir

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53807-177
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	220 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53807-177-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999
2	NDC: 53807-177-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		03/16/1999

Labeler - Rij Pharmaceutical Corporation (144679156)

Establishment
Name	Address	ID/FEI	Business Operations
Rij Pharmaceutical Corporation		144679156	manufacture(53807-177)