SPL v1
SPL
SPL Set ID c10bb804-8169-63da-e053-2a95a90a8306
Route
ORAL
Published
Effective Date 2021-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (3 [hp_X]) Chloride Ion (6 [hp_X]) Phosphate Ion (1 [hp_X]) Zinc Cation Fluoride Ion Potassium Cation Silicon Dioxide Ferrosoferric Phosphate Sulfate Ion Sodium Sulfate Anhydrous Magnesium Cation
Inactive Ingredients
Xylitol Hyaluronic Acid Magnesium Stearate Lactose Monohydrate Microcrystalline Cellulose European Elderberry Juice

Identifiers & Packaging

Pill Appearance
Shape: round Color: purple Size: 5 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-07-01

Description

Active ingredients Equal amounts of: Calc fluor 6X HPUS, Calc phos 3X HPUS, Calc sulph 3X HPUS, Ferrum phos 3X HPUS, Kali mur 3X HPUS, Kali phos 3X HPUS, Kali sulph 3X HPUS, Mag phos 3X HPUS, Nat mur 6X HPUS, Nat phos 3X HPUS, Nat sulph 3X HPUS, Silicea 6X HPUS, Zinc gluc 1X HPUS "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopeia of the United States.


Medication Information

Warnings and Precautions

Warnings

Do not use if seal under cap is broken or missing. Consult physician before use if the child has medical condition or is taking any medication. Do not use more often than directed or if your child has a known allergy to any ingredient in this product.

Indications and Usage

Provides a daily supply of Vital 12 cell salts to help balance and support overall cell functions. Provides zinc and elderberry to help with immune support.+

Dosage and Administration

Directions

  • Infant Ages 3m - 1 year: 1 tablet
  • Children Ages 2 - 6 years: 2 tablets
  • Adults & Children Ages 7+ years: 4 tablets

Dissolve under tongue 4 times a day. Tablets may be crushed or dissolved in a teaspoon of water.

Description

Active ingredients Equal amounts of: Calc fluor 6X HPUS, Calc phos 3X HPUS, Calc sulph 3X HPUS, Ferrum phos 3X HPUS, Kali mur 3X HPUS, Kali phos 3X HPUS, Kali sulph 3X HPUS, Mag phos 3X HPUS, Nat mur 6X HPUS, Nat phos 3X HPUS, Nat sulph 3X HPUS, Silicea 6X HPUS, Zinc gluc 1X HPUS "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Section 50565-1

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if irritation, swelling, or rash develops.

Section 51727-6

Inactive ingredients

Elderberry Juice Powder, Hyaluronic Acid, Lactose, Magnesium Stearate, Maltodextrin, Microcrystalline, Cellulose, Xylitol. Contains lactose from milk.

Section 51945-4

Section 53413-1

Questions or comments?

Call us at 1-855-366-7755 (U.S.A. only) M-F 8AM-5PM CST

+Claims based on traditional homeopathic practices, not accepted medical evidence. Not FDA evaluated.

Section 55105-1

Provides a daily supply of Vital 12 cell salts to help balance and support overall cell functions. Provides zinc and elderberry to help with immune support.+

Section 55106-9

Active ingredients

Equal amounts of: Calc fluor 6X HPUS, Calc phos 3X HPUS, Calc sulph 3X HPUS, Ferrum phos 3X HPUS, Kali mur 3X HPUS, Kali phos 3X HPUS, Kali sulph 3X HPUS, Mag phos 3X HPUS, Nat mur 6X HPUS, Nat phos 3X HPUS, Nat sulph 3X HPUS, Silicea 6X HPUS, Zinc gluc 1X HPUS

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Section 60561-8

Other information

Do not use if seal under cap is broken or missing. Store tablets in dry conditions at room temperature.


Structured Label Content

Indications and Usage (34067-9)

Provides a daily supply of Vital 12 cell salts to help balance and support overall cell functions. Provides zinc and elderberry to help with immune support.+

Dosage and Administration (34068-7)

Directions

  • Infant Ages 3m - 1 year: 1 tablet
  • Children Ages 2 - 6 years: 2 tablets
  • Adults & Children Ages 7+ years: 4 tablets

Dissolve under tongue 4 times a day. Tablets may be crushed or dissolved in a teaspoon of water.

Warnings and Precautions (34071-1)

Warnings

Do not use if seal under cap is broken or missing. Consult physician before use if the child has medical condition or is taking any medication. Do not use more often than directed or if your child has a known allergy to any ingredient in this product.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation, swelling, or rash develops.

Section 51727-6 (51727-6)

Inactive ingredients

Elderberry Juice Powder, Hyaluronic Acid, Lactose, Magnesium Stearate, Maltodextrin, Microcrystalline, Cellulose, Xylitol. Contains lactose from milk.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call us at 1-855-366-7755 (U.S.A. only) M-F 8AM-5PM CST

+Claims based on traditional homeopathic practices, not accepted medical evidence. Not FDA evaluated.

Section 55105-1 (55105-1)

Provides a daily supply of Vital 12 cell salts to help balance and support overall cell functions. Provides zinc and elderberry to help with immune support.+

Section 55106-9 (55106-9)

Active ingredients

Equal amounts of: Calc fluor 6X HPUS, Calc phos 3X HPUS, Calc sulph 3X HPUS, Ferrum phos 3X HPUS, Kali mur 3X HPUS, Kali phos 3X HPUS, Kali sulph 3X HPUS, Mag phos 3X HPUS, Nat mur 6X HPUS, Nat phos 3X HPUS, Nat sulph 3X HPUS, Silicea 6X HPUS, Zinc gluc 1X HPUS

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Section 60561-8 (60561-8)

Other information

Do not use if seal under cap is broken or missing. Store tablets in dry conditions at room temperature.


Advanced Ingredient Data


Raw Label Data

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