SPL v4
SPL
SPL Set ID 114d3161-782f-4475-857a-188105607d67
Route
ORAL
Published
Effective Date 2021-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Keep out of reach of children


Medication Information

Warnings and Precautions

If pregnant or breast-feeding , ask a health professional before use. If symptoms persist or worsen, a healthcare professional should be consulted. Do not use if known sensitivity to BHI Arnica + or any of its ingredients exists.

Indications and Usage

For the temporary relief of pain due to overexertion, bruises, minor injuries

Dosage and Administration

Directions: At first sign of symptoms:Adults and children 4 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage.  Standard dosage: Adults and children 4 years and older: 1-2 tablets every 4 to 6 hours. Do not exceed 12 tablets in 24 hours. For children under 4, consult your health professional. Allow tablets to dissolve completely in the mouth, do not swallow

Description

Keep out of reach of children

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients: **Dextrose, ** Lactose, Magnesium Stearate, **Maltodextrin **contains one or more of these ingredients.

Section 51945-4

BHI Arnica + Tablet.jpg

Section 55105-1

Relieves Pain due to: • Overexertion • Bruises • Minor Injury

Section 55106-9

Active Ingredients: Each tablet contains: *Arnica montana, radix 6X, 12X, 30X, 200X, 75 mg each. *Natural ingredients


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain due to overexertion, bruises, minor injuries

Dosage and Administration (34068-7)

Directions: At first sign of symptoms:Adults and children 4 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage.  Standard dosage: Adults and children 4 years and older: 1-2 tablets every 4 to 6 hours. Do not exceed 12 tablets in 24 hours. For children under 4, consult your health professional. Allow tablets to dissolve completely in the mouth, do not swallow

Warnings and Precautions (34071-1)

If pregnant or breast-feeding , ask a health professional before use. If symptoms persist or worsen, a healthcare professional should be consulted. Do not use if known sensitivity to BHI Arnica + or any of its ingredients exists.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients: **Dextrose, ** Lactose, Magnesium Stearate, **Maltodextrin **contains one or more of these ingredients.

Section 51945-4 (51945-4)

BHI Arnica + Tablet.jpg

Section 55105-1 (55105-1)

Relieves Pain due to: • Overexertion • Bruises • Minor Injury

Section 55106-9 (55106-9)

Active Ingredients: Each tablet contains: *Arnica montana, radix 6X, 12X, 30X, 200X, 75 mg each. *Natural ingredients


Raw Label Data

All Sections (JSON)