FERROUS SULFATE solution

FERROUS SULFATE by

Drug Labeling and Warnings

FERROUS SULFATE by is a Other medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts 

Serving Size: 5mL (1 Unit Dose)
Amount per serving		% Daily Value*
Calories	4
Total Carbohydrate	1g	<1%
Sugars	1g	**
Includes 1g Added Sugars		4%
Iron (elemental); (as ferrous sulfate)	60mg	333%
*Percent Daily Value based on a 2,000 calorie diet; **Daily Value not established

HEALTH CLAIM

Other ingredients: Purified water, sucrose, citric acid, sodium benzoate, and cinnamon flavor.

Use: Ferrous Sulfate Oral Solution is an iron supplement for the treatment and prevention of iron deficiency and iron deficient anemia when the need for such therapy has been determined by a healthcare professional.†

Directions:

May be mixed with water or fruit juice and drink through a straw to avoid temporary staining of teeth. Do not mix with milk or wine based vehicles.
As directed by a doctor or as follows

• Prevention of iron deficiency
  Adults: 5mL (1 unit dose) daily
  Children under 12 years of age: Consult of doctor
• Iron replacement therapy in deficiency states
  Adults: 5mL (1 unit dose) two (2) to four (4) times daily preferable between meals
  Children under 12 years of age: Consult of doctor

SAFE HANDLING WARNING

Do not use

• If you are taking other iron containing supplements
• For more than six months unless directed by a doctor

Oral Iron Supplements

• May interfere with absorption of certain antibiotics (e.g. tetracycline and other medications). These products should not be taken with two (2) hours of each other.
• May cause occasional bowel effects such as constipation or diarrhea.

WARNINGS

Warnings

Do not exceed recommended dosage: The treatment of anemic conditions should be under the advice and supervision of a doctor. Occasional gastrointestinal or discomfort (such as nausea) may be minimized by taking supplement between meals. Also in order to minimize gastrointestinal or discomfort, may begin by taking 5 mL (1 unit dose) and increase dosage over time. Staining of teeth may occur with ferrous sulfate oral solution.

Warning: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under six (6). Keep out of reach of children. In case of accidental overdose call a doctor or contact a Poison Control Center right away. (1-880-222-1222)

PRECAUTIONS

If pregnant or breast-feeding, ask a doctor before use.

DOSAGE & ADMINISTRATION

Storage

store at 20° to 25°C (68°to 77°F). [See USP Controlled Room Temperature]
preserve in tight, light-resistant containers
protect from freezing and light
do not use if lid is torn or broken

Questions or comments? Call-1-844-474-7464
†This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
FG-27/Iss.:03/2023

PRINCIPAL DISPLAY PANEL

Case label -57237-311-51 (100 x 5 mL Unit-Dose Cups)

Lid Label -57237-311-05 (Delivers 5 mL)

INGREDIENTS AND APPEARANCE

FERROUS SULFATE 
ferrous sulfate solution

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:57237-311
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	300 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:57237-311-51	100 in 1 BOX, UNIT-DOSE
1	NHRIC:57237-311-05	5 mL in 1 CUP, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		05/22/2023

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
flavor

Labeler - Rising Pharma Holdings, Inc. (116880195)