Ferrous Sulfate Elixir

Basic Information

Product Label

Product label for Ferrous Sulfate Elixir
Full Name: Ferrous Sulfate Elixir
Brand: Hi-Tech Pharmacal none
Product Type: Mineral
Physical State: Liquid
Status: Off Market
Product Version Code: Rev. 778:00 11/09 MG #28535

Contact Information

Questions or comments? Call

Phone: 1-888-262-9010
Types: Other
Name: Hi-Tech Pharmacal Co., Inc.
Address:Amityville, NY, 11701
Types: Manufacturer

Product Details

Net Contents

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

Serving Sizes

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

Target Groups

Adult (18 - 50 Years)

Ingredients & Nutrition

Notes: Ferrous Sulfate Note: (USP) (Equivalent to approximately 44 mg of elemental iron)

Amount: 220 mg
Serving Size: 5 mL

Group: Iron

alcohol 5%

non-nutrient/non-botanical

Group: Alcohol

Group: Flavor

Group: Corn Syrup

UNII Code: 9G5L16BK6N

Group: Color

Group: Water

Group: Sodium Benzoate

Sodium Saccharin

non-nutrient/non-botanical

Group: Saccharin

Sucrose

sugar

Group: Sucrose

UNII Code: C151H8M554

Product Statements

General Statements: All Other Content

Citric acid may be used to adjust pH.

Precautions re: All Other

WARNINGS: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea. Liquids may cause temporary staining of the teeth. This is less likely when the product is diluted.

Storage

STORAGE: Keep tightly closed. Store at controlled room temperature, 15(0)-30(0)C (59(0)-86(0)F). Protect from freezing. Protect from light.

General: Product/Version Code

Rev. 778:00 11/09 MG #28535

Formula re: Contains

CONTAINS ALCOHOL 5%

FDA Statement of Identity

IRON SUPPLEMENT

Formula re: Contains

DESCRIPTION: Each 5 mL (1 teaspoonful) contains ferrous sulfate USP, 220 mg. (Equivalent to approximately 44 mg of elemental iron).

General Statements: All Other Content

INDICATIONS: For the prevention and treatment of iron deficiency and iron-deficiency anemia when the need for such therapy has been determined by a physician.

Suggested/Recommended/Usage/Directions

DIRECTIONS: As directed by a physician or as follows: Adults: 5 mL (1 teaspoonful) one time daily preferably on an empty stomach one hour before or two hours after meals. Children under 12 years of age: consult a physician. Mix with water or fruit juice to avoid temporary staining of teeth; do not mix with milk or wine-based vehicles.

Precautions re: Pregnant or Nursing or Prescription Medications

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

General Statements: All Other Content

HOW SUPPLIED: Yellow colored, cherry flavored clear liquid supplied in the following oral dosage form: unit dose of 220 mg/5 mL, 10 cups per tray; 16 fl. oz. (473 mL) bottle.

Precautions re: Children

KEEP THIS AND ALL DRUGS OUT OF THE 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 immediately.

Precautions re: Pregnant or Nursing or Prescription Medications

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.

General Statements: All Other Content

Ferrous Sulfate Elixir Liquid Iron Preperation

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