ONE VITE IRON SUPPLEMENT LIQUID- ferrous sulfate liquid

ONE VITE Iron Supplement Liquid by

Drug Labeling and Warnings

ONE VITE Iron Supplement Liquid by is a Other medication manufactured, distributed, or labeled by Akron Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

• Amount per teaspoonful (5 mL) %Daily Value *: % Daily Value
• Total Carbohydrate 1g: <1%
• Total Sugars 1g: **
• includes 1g Added Sugars: 2%
• Iron (elemental)(from ferrous sulfate) 44mg: 244%

HEALTH CLAIM

Each teaspoonful (5mL) contains 220mg Ferrous Sulfate, providing approximately 44mg of elemental iron.

OTHER INGREDIENTS: Anhydrous citric acid, Dye FD&C yellow #6, Flavor cherry, Sodium Benzoate, Sucralose, Sucrose, Purified water.

SAFE HANDLING WARNING

WARNING: Accidental overdose of iron containing supplements is a leading cause of fatal poisoning in children under 6.
KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.
In case of accidental overdose, call a doctor or Poison Control Center immediately.

WARNINGS

see boxed warning above.

PRECAUTIONS

CAUTION: Do not exceed suggested serving size.

The treatment of any anemic condition should be under the advice and supervision of a doctor. Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two (2) hours of each other.
This product may occasionally cause constipation, diarrhea, or may color stool black. It may cause gastrointestinal discomfort (such as nausea) which may be minimized by taking with meals.
As with any supplement, if you are pregnant, nursing, taking medication, or under a doctor's care for any condition, ask a health professional before use.
OTHER INFORMATION: Store at room temperature 15-30°C (59-86°F)

Tamper-Evident: Do not use if foil seal over bottle opening is torn, broken or missing.
Pharmacist: Dispense in a tight, light-resistant container with a child resistant cap as defined in the USP.

DOSAGE & ADMINISTRATION

SUGGESTED USE: Adults and children 12 years and over, take one (1) teaspoonful daily with or after a meal as a dietary supplement, or as directed by your doctor.
Children under 12, consult a doctor.
Mix with water or juice to avoid temporary staining of teeth. Do not mix with milk or wine-based vehicles.

Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
www.akronpharma.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONE VITE IRON SUPPLEMENT LIQUID 
ferrous sulfate liquid

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:71399-0040
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71399-0040-6	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		08/04/2023

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

Labeler - Akron Pharma (067878881)