FeroSul 220 mg

Basic Information

Product Label

Product label for FeroSul 220 mg
Full Name: FeroSul 220 mg
Brand: Major ®
Product Type: Mineral
Physical State: Liquid
UPC/SKU: 3 0904 146516 9
Product Version Code: Re-order No. 245837 M-62 Rev. 07/09

Contact Information

Distributed by

Name: Major Pharmaceuticals
Address:31778 Enterprise Drive, Livonia, MI, 48150
Country: USA
Phone: (800) 616-2471
Types: Distributor

Product Details

Net Contents

473 mL(473 mL)
16 fl. Oz.(16 fl. Oz.)

Serving Sizes

Unit:tsp
Quantity:1 - 1
Daily Servings:1 - 1
Notes:5 mL

Target Groups

Children 4 or More Years of AgeAdult (18 - 50 Years)

Servings Per Container

94

Ingredients & Nutrition

Alcohol

non-nutrient/non-botanical

Group: Alcohol

UNII Code: 3K9958V90M

Group: Vitamin C

Also known as: Vitamin C, Vit. C

UNII Code: PQ6CK8PD0R

Group: Color

Group: Iron

UNII Code: 39R4TAN1VT

Lemon Flavor

botanical

Group: Lemon

Group: Propylene Glycol

UNII Code: 6DC9Q167V3

Saccharin Sodium

non-nutrient/non-botanical

Group: Saccharin

Group: Sodium Benzoate

Also known as: Na Benzoate

UNII Code: OJ245FE5EU

Sorbitol Solution

non-nutrient/non-botanical

Group: Sorbitol

Sucrose

sugar

Group: Sucrose

UNII Code: C151H8M554

Group: Vitamin C (ascorbic acid)

Also known as: Ascorbic Acid

Product Statements

General Statements: All Other Content

Uses: Iron supplements are used to treat or prevent low blood levels or iron, such as for anemia or during pregnancy.

Precautions re: All Other

Warnings Iron containing products should only be taken for very specific reasons and only under the advice and supervision of a doctor.

Precautions re: Pregnant or Nursing or Prescription Medications

Consult your doctor for guidance for iron supplementation.

Precautions re: All Other

Do not exceed recommended dosage.

Precautions re: Children

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

Precautions re: Allergies

Do not use if you are allergic to any ingredient in Ferrous Sulfate Elixir - you have high levels of iron in your blood.

Precautions re: All Other

Do not use if you are allergic to any ingredient in Ferrous Sulfate Elixir - you have high levels of iron in your blood.

General Statements: All Other Content

NDC 0904-1465-16

Formula re: Contains

Ferrous Sulfate Elixir Contains alcohol 5%

Formula re: Contains

Ferrous Sulfate 220 mg/5 mL (equivalent to 44 mg iron)

Precautions re: Children

Bulk container - not for household use This container is not child-resistant. Pharmacist - Dispense in a child-resistant container

Precautions re: All Other

Do not accept if imprinted safety seal around cap is broken or missing

Precautions re: Pregnant or Nursing or Prescription Medications

Ask a doctor before use if - you are pregnant, planning to become pregnant, or are breast-feeding - you are taking any prescription or over-the-counter medicines

Precautions re: Pregnant or Nursing or Prescription Medications

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

Precautions re: All Other

Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron containing medications may occasionally cause constipation or diarrhea, and may cause temporary staining of the teeth. Mixing Ferrous Sulfate Elixir with water or fruit juice may help to decrease the effects. Do not take Ferrous Sulfate Elixir within 1 hour before or 2 hours after antacids, eggs, milk, milk byproducts, coffee, or tea.

Suggested/Recommended/Usage/Directions

Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron containing medications may occasionally cause constipation or diarrhea, and may cause temporary staining of the teeth. Mixing Ferrous Sulfate Elixir with water or fruit juice may help to decrease the effects. Do not take Ferrous Sulfate Elixir within 1 hour before or 2 hours after antacids, eggs, milk, milk byproducts, coffee, or tea.

Precautions re: All Other

Directions Do not exceed recommended dosage.

Suggested/Recommended/Usage/Directions

Directions Do not exceed recommended dosage. Do not mix with milk, milky byproducts, or wine-based vehicles. Adults 1 teaspoonful daily or as directed by a doctor Children under 12 years Consult a doctor

Storage

Other information Store at room temperature 20(0)-25(0)C (68(0)-77(0)F), protect from freezing.

Precautions re: All Other

To report adverse drug events call, 800-616-2471

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