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SPL v1

SPL

SPL Set ID 73775ef1-bed4-432c-b16e-6f72513bb89c

Route

ORAL

Published

Effective Date 2016-04-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (6 [hp_X]) Ferrosoferric Phosphate (3 [hp_X]) Magnesium Cation

Inactive Ingredients

Lactose

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2016-04-05

Description

CALCAREA FLUORICA 6X HPUS, FERRUM PHOSPHORICUM 3X HPUS,MAGNESIA PHOSPHORICA 3X HPUS

Medication Information

Description

CALCAREA FLUORICA 6X HPUS, FERRUM PHOSPHORICUM 3X HPUS,MAGNESIA PHOSPHORICA 3X HPUS

Uses

Toothache

Dosage

Adults- Take 4 or 6 tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

Section 50565-1

Keep this and all medication out of reach of children

Section 50566-9

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

Section 50570-1

Do not use if capseal is broken or missing.

Close the cap tightly after use.

Section 51945-4

Section 53414-9

As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

Storage

Store in a cool dark place

Warnings

This product is to be used for self-limiting conditions.

Indications

Condition listed above or as directed by the physician

Active Ingredient

CALCAREA FLUORICA 6X HPUS, FERRUM PHOSPHORICUM 3X HPUS,MAGNESIA PHOSPHORICA 3X HPUS

Inactive Ingredients

Lactose

Questions Or Comments

www.Rxhomeo.com | 1.888.2796642 | [email protected]

Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

Structured Label Content

Uses (USES)

Toothache

Dosage (DOSAGE)

Adults- Take 4 or 6 tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

Section 50565-1 (50565-1)

Keep this and all medication out of reach of children

Section 50566-9 (50566-9)

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

Section 50570-1 (50570-1)

Do not use if capseal is broken or missing.

Close the cap tightly after use.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

Storage (STORAGE)

Store in a cool dark place

Warnings (WARNINGS)

This product is to be used for self-limiting conditions.

Indications (INDICATIONS)

Condition listed above or as directed by the physician

Active Ingredient (ACTIVE INGREDIENT)

CALCAREA FLUORICA 6X HPUS, FERRUM PHOSPHORICUM 3X HPUS,MAGNESIA PHOSPHORICA 3X HPUS

Inactive Ingredients (INACTIVE INGREDIENTS)

Lactose

Questions Or Comments (QUESTIONS OR COMMENTS)

www.Rxhomeo.com | 1.888.2796642 | [email protected]

Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "FERROSOFERRIC PHOSPHATE", "unii": "91GQH8I5F7", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM CATION", "unii": "T6V3LHY838", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "Toothache", "DOSAGE": "Adults- Take 4 or 6 tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.", "50565-1": "Keep this and all medication out of reach of children", "50566-9": "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional", "50570-1": "Do not use if capseal is broken or missing. Close the cap tightly after use.", "53414-9": "As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product", "STORAGE": "Store in a cool dark place", "WARNINGS": "This product is to be used for self-limiting conditions.", "INDICATIONS": "Condition listed above or as directed by the physician", "ACTIVE INGREDIENT": "CALCAREA FLUORICA 6X HPUS, FERRUM PHOSPHORICUM 3X HPUS,MAGNESIA PHOSPHORICA 3X HPUS", "INACTIVE INGREDIENTS": "Lactose", "QUESTIONS OR COMMENTS": "www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:38.368693 · Updated: 2026-03-14T23:14:37.915929