SPL v1
SPL
SPL Set ID b29e3d0e-10ee-3460-e053-2995a90a1993
Route
ORAL
Published
Effective Date 2020-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (12 [hp_X])
Inactive Ingredients
Lactose Monohydrate

Identifiers & Packaging

Pill Appearance
Imprint: SBL Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-11-10
Description

Calcarea Fluorica 12X

Medication Information

Warnings and Precautions

Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

Do not use if tamper evident seal is missing or broken.

Indications and Usage

Temporary relief from minor joint pain, sensitive teeth, cracked skin.

Dosage and Administration

Adults and children 12 years of age and older: Four tablets every thirty minutes for six doses followed by four tablets every 4-6 hours as needed.

Children 2 years to 12 years of age: Four tablets every thirty minutes for six doses followed by two tablets every 4-6 hours as needed.

Children under 2 years of age: Consult doctor prior to use.

Description

Calcarea Fluorica 12X

Section 50565-1

Keep out of reach of children.

Section 51727-6

Lactose

Section 51945-4

Section 55105-1

Temporary relief of minor joint pain, sensitive teeth, cracked skin.

Section 55106-9

Calcarea Fluorica 12X

Structured Label Content

Indications and Usage (34067-9)

Temporary relief from minor joint pain, sensitive teeth, cracked skin.

Dosage and Administration (34068-7)

Adults and children 12 years of age and older: Four tablets every thirty minutes for six doses followed by four tablets every 4-6 hours as needed.

Children 2 years to 12 years of age: Four tablets every thirty minutes for six doses followed by two tablets every 4-6 hours as needed.

Children under 2 years of age: Consult doctor prior to use.

Warnings and Precautions (34071-1)

Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

Do not use if tamper evident seal is missing or broken.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Lactose

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Temporary relief of minor joint pain, sensitive teeth, cracked skin.

Section 55106-9 (55106-9)

Calcarea Fluorica 12X

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:55.782706 · Updated: 2026-03-14T23:14:58.948891