Vitamin D Supplement Drops

Basic Information

Product Label

Product label for Vitamin D Supplement Drops
Full Name: Vitamin D Supplement Drops
Brand: Hi-Tech Pharmacal none
Product Type: Vitamin
Physical State: Liquid
Status: Off Market
Product Version Code: Rev.917:00 11/10

Contact Information

Name: Hi-Tech Pharmacal Co., Inc.
Address:Amityville, NY, 11701
Types: Manufacturer

Product Details

Net Contents

1.67 fl. Oz.(1.67 fl. Oz.)
50 mL(50 mL)

Serving Sizes

Unit:mL
Quantity:1 - 1
Daily Servings:1 - 1
Notes:Dropperful Daily

Target Groups

Infants/Baby (0 - 1 Year)Gluten FreeDairy FreeSugar FreeChildren more than 1 but less than 4

Servings Per Container

50

Ingredients & Nutrition

Vitamin D

vitamin
Amount: 400 IU
Serving Size: 1 mL
Infants: 100%
Children less than 4 years of age: 100%

Group: Vitamin D

Group: Flavor

Caramel

other

Group: Flavor

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Citric Acid

non-nutrient/non-botanical

Group: Citric Acid

Group: Glycerol

Group: Vitamin D (cholecalciferol)

Also known as: Cholecalciferol

Group: Polysorbate

Group: Water

Group: Sodium Citrate

Also known as: Na Citrate

UNII Code: 1Q73Q2JULR

Product Statements

Formula re: Type

The American Academy of Pediatrics (AAP) recommends using a Vitamin D supplement for exclusively and partially breastfed babies because of low average levels of Vitamin D in breast milk.

Formula re: Type

Essential for All breastfed infants

FDA Statement of Identity

Supplement Drops

General Statements: All Other Content

Compare to Vitamin D content in D-Vi-Sol Drops

Formulation re: Other

Vitamin D Supplement Drops (1 mL dose) meets the 400 IU of Vitamin D recommended by the AAP for all breastfed infants. Vitamin D Supplement Drops provides an essential vitamin that helps your baby's body absorb calcium for strong bones and teeth. Vitamin D Supplement Drops complements your breast milk to help provide optimal nutrition for your baby.

Formulation re: Does NOT Contain

Vitamin D Supplement Drops is sugar-free, gluten-free, and lactose-free.

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

General Statements: All Other Content

Retain carton for complete product information, directions, and warnings.

Precautions re: Children

Keep this and all drugs out of reach of children.

Precautions re: All Other

Tamper Evident: Do not use if the safety seal under the cap is broken or missing.

Precautions re: Children

Your physician is the best guidance in vitamin supplementation for your child.

General Statements: All Other Content

Questions or comments? Call 1-800-262-9010 Mon - Thur. 9:00 am - 4:30 pm EST. Fri. 9:00 am - 2:30 pm EST.

Precautions re: All Other

Serious side effects associated with use of this product may be reported to this number.

Suggested/Recommended/Usage/Directions

Dosage and administration Administer 1.0 mL, or as prescribed, using the dropper provided. Fill the dropper to the line (1.0 mL). Dispense with a single squeeze of the dropper bulb. The full prescribe daily dose will be given. Use full dosage, regardless of age or weight, unless your child's doctor recommends a different dosage. It is normal for a small amount to remain in the tip of the dropper. May be dropped directly into the mouth or also be mixed with breast milk, formula, cereal or other foods. Use full dosage.

General Statements: All Other Content

How Supplied Vitamin D supplement Drops are available in 50 mL bottle with accompanying calibrated dropper.

Storage

Recommended Storage Refrigeration not required. After opening, store away from direct light.

Brand IP Statement(s) re: (c), (TM), (SM)

This product is not distributed by Mead Johnson, owner of the registered trademark D-Vi-Sol Drops.

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