Liquical Plus

Liquical Plus
SPL v2
SPL
SPL Set ID 1ab92efb-ae5a-b71c-e063-6294a90a60d1
Route
ORAL
Published
Effective Date 2024-06-12
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cholecalciferol (1200 [iU]) Zinc Cation (2.1 mg) Magnesium Cation (72 mg)
Inactive Ingredients
Potassium Sorbate Water Anhydrous Citric Acid Xanthan Gum Agave Tequilana Stem

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-06-12

Description

LiquiCal™ Plus Rx Only Full Prescribing Information Active Ingredients: Each 5 mL Contains: Vitamin D3 (as Cholecalciferol) ................................................................. 10 mcg (400 IU) Calcium (as Calcium Citrate) ..................................................................................... 84 mg Magnesium (as Magnesium Citrate) ......................................................................... 24 mg Zinc (as Zinc Citrate) ................................................................................................ 0.7 mg Each 15 mL Contains: Vitamin D3 (as Cholecalciferol) ............................................................... 30 mcg (1200 IU) Calcium (as Calcium Citrate) ................................................................................... 252 mg Magnesium (as Magnesium Citrate) ......................................................................... 72 mg Zinc (as Zinc Citrate) ................................................................................................ 2.1 mg Other Ingredients: Agave Tequilana (Tequila Agave) Stem Extract, Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum.

Dosage and Administration

Shake well before use . For Children 1-3 years: 1-2 teaspoons (5-10 mL) daily For Children 4+ years: 1 tablespoon (15 mL) up to 2 times daily LiquiCal™ Plus should be administered under the supervision of a licensed healthcare practitioner.

Warnings and Precautions

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breastfeeding. Consult your doctor.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. LiquiCal™ Plus is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Adverse Reactions

Adverse reactions are rare but may include gastrointestinal disturbances such as nausea or constipation. If adverse reactions occur, discontinue use and consult a healthcare professional. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation , at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How Supplied

LiquiCal™ Plus is available in a 480 mL white HDPE bottle with NDC 59088-201-31.


Medication Information

Warnings and Precautions

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breastfeeding. Consult your doctor.

Dosage and Administration

Shake well before use . For Children 1-3 years: 1-2 teaspoons (5-10 mL) daily For Children 4+ years: 1 tablespoon (15 mL) up to 2 times daily LiquiCal™ Plus should be administered under the supervision of a licensed healthcare practitioner.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. LiquiCal™ Plus is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Adverse Reactions

Adverse reactions are rare but may include gastrointestinal disturbances such as nausea or constipation. If adverse reactions occur, discontinue use and consult a healthcare professional. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation , at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How Supplied

LiquiCal™ Plus is available in a 480 mL white HDPE bottle with NDC 59088-201-31.

Description

LiquiCal™ Plus Rx Only Full Prescribing Information Active Ingredients: Each 5 mL Contains: Vitamin D3 (as Cholecalciferol) ................................................................. 10 mcg (400 IU) Calcium (as Calcium Citrate) ..................................................................................... 84 mg Magnesium (as Magnesium Citrate) ......................................................................... 24 mg Zinc (as Zinc Citrate) ................................................................................................ 0.7 mg Each 15 mL Contains: Vitamin D3 (as Cholecalciferol) ............................................................... 30 mcg (1200 IU) Calcium (as Calcium Citrate) ................................................................................... 252 mg Magnesium (as Magnesium Citrate) ......................................................................... 72 mg Zinc (as Zinc Citrate) ................................................................................................ 2.1 mg Other Ingredients: Agave Tequilana (Tequila Agave) Stem Extract, Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum.

Storage:

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Protect from heat, light, and moisture.

Tamper Evident: Do not use if the seal is broken or missing

Indications:

LiquiCal™ Plus is indicated for dietary management of patients with unique nutritional needs requiring increased Vitamin D3 and essential minerals, including Calcium, Magnesium, and Zinc in a convenient liquid form for easy administration.

How Supplied:

LiquiCal™ Plus is available in a 480 mL white HDPE bottle with NDC 59088-201-31.

Liquical™ Plus

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information call toll-free: 877-921-7873

Drug Description:

LiquiCal™ Plus

Rx Only


Full Prescribing Information

Active Ingredients:

Each 5 mL Contains:


Vitamin D3 (as Cholecalciferol) ................................................................. 10 mcg (400 IU)

Calcium (as Calcium Citrate) ..................................................................................... 84 mg

Magnesium (as Magnesium Citrate) ......................................................................... 24 mg

Zinc (as Zinc Citrate) ................................................................................................ 0.7 mg



Each 15 mL Contains:

Vitamin D3 (as Cholecalciferol) ............................................................... 30 mcg (1200 IU)

Calcium (as Calcium Citrate) ................................................................................... 252 mg

Magnesium (as Magnesium Citrate) ......................................................................... 72 mg

Zinc (as Zinc Citrate) ................................................................................................ 2.1 mg



Other Ingredients: Agave Tequilana (Tequila Agave) Stem Extract, Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum.

Adverse Reactions:

Adverse reactions are rare but may include gastrointestinal disturbances such as nausea or constipation. If adverse reactions occur, discontinue use and consult a healthcare professional.

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindications:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. LiquiCal™ Plus is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Clinical Pharmacology

Vitamin D3 is essential for calcium absorption in the gut and maintaining adequate serum calcium and phosphate concentrations, supporting bone mineralization and immune function.

Calcium is crucial for the development and maintenance of healthy bones and teeth, as well as muscle function.

Magnesium is important for muscle and nerve function, blood glucose control, and bone health.

Zinc supports normal growth and development, immune function, and wound healing.

Warnings and Precautions:

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breastfeeding. Consult your doctor.

Dosage and Administration:

Shake well before use.

For Children 1-3 years: 1-2 teaspoons (5-10 mL) daily

For Children 4+ years: 1 tablespoon (15 mL) up to 2 times daily



LiquiCal™ Plus should be administered under the supervision of a licensed healthcare practitioner.


Structured Label Content

Storage: (STORAGE:)

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Protect from heat, light, and moisture.

Tamper Evident: Do not use if the seal is broken or missing

Indications: (INDICATIONS:)

LiquiCal™ Plus is indicated for dietary management of patients with unique nutritional needs requiring increased Vitamin D3 and essential minerals, including Calcium, Magnesium, and Zinc in a convenient liquid form for easy administration.

How Supplied: (HOW SUPPLIED:)

LiquiCal™ Plus is available in a 480 mL white HDPE bottle with NDC 59088-201-31.

Liquical™ Plus (LiquiCal™ Plus)

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information call toll-free: 877-921-7873

Drug Description: (DRUG DESCRIPTION:)

LiquiCal™ Plus

Rx Only


Full Prescribing Information

Active Ingredients:

Each 5 mL Contains:


Vitamin D3 (as Cholecalciferol) ................................................................. 10 mcg (400 IU)

Calcium (as Calcium Citrate) ..................................................................................... 84 mg

Magnesium (as Magnesium Citrate) ......................................................................... 24 mg

Zinc (as Zinc Citrate) ................................................................................................ 0.7 mg



Each 15 mL Contains:

Vitamin D3 (as Cholecalciferol) ............................................................... 30 mcg (1200 IU)

Calcium (as Calcium Citrate) ................................................................................... 252 mg

Magnesium (as Magnesium Citrate) ......................................................................... 72 mg

Zinc (as Zinc Citrate) ................................................................................................ 2.1 mg



Other Ingredients: Agave Tequilana (Tequila Agave) Stem Extract, Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum.

Adverse Reactions: (ADVERSE REACTIONS:)

Adverse reactions are rare but may include gastrointestinal disturbances such as nausea or constipation. If adverse reactions occur, discontinue use and consult a healthcare professional.

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindications: (CONTRAINDICATIONS:)

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. LiquiCal™ Plus is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Clinical Pharmacology (CLINICAL PHARMACOLOGY)

Vitamin D3 is essential for calcium absorption in the gut and maintaining adequate serum calcium and phosphate concentrations, supporting bone mineralization and immune function.

Calcium is crucial for the development and maintenance of healthy bones and teeth, as well as muscle function.

Magnesium is important for muscle and nerve function, blood glucose control, and bone health.

Zinc supports normal growth and development, immune function, and wound healing.

Warnings and Precautions: (WARNINGS AND PRECAUTIONS:)

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breastfeeding. Consult your doctor.

Dosage and Administration: (DOSAGE AND ADMINISTRATION:)

Shake well before use.

For Children 1-3 years: 1-2 teaspoons (5-10 mL) daily

For Children 4+ years: 1 tablespoon (15 mL) up to 2 times daily



LiquiCal™ Plus should be administered under the supervision of a licensed healthcare practitioner.


Advanced Ingredient Data


Raw Label Data

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