SPL v3
SPL
SPL Set ID 78283f27-d86d-4fa1-ab3d-f6ad62c30eac
Route
ORAL
Published
Effective Date 2022-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . If symptoms persist or worsen, a health professional should be consulted. Do not use if sensitivity to Pain & Injury Relief or any of its ingredients exists. In case of accidental overdose, contact a poison control center immediately.


Medication Information

Warnings and Precautions

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . If symptoms persist or worsen, a health professional should be consulted. Do not use if sensitivity to Pain & Injury Relief or any of its ingredients exists. In case of accidental overdose, contact a poison control center immediately.

Indications and Usage

For the temporary relief of: • Pain • Headache • General fatigue • Back pain

Dosage and Administration

Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times daily or as directed by a physician. If symptoms persist, take 1 tablet every 30 minutes; not to exceed 12 tablets daily.

Description

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . If symptoms persist or worsen, a health professional should be consulted. Do not use if sensitivity to Pain & Injury Relief or any of its ingredients exists. In case of accidental overdose, contact a poison control center immediately.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

Lactose, Magnesium stearate

Section 51945-4

Add image transcription here...

Section 55105-1

Pain & Injury Relief

Section 55106-9

Each tablet contains equal parts of Aconitum napellus 4X; Arnica montana, radix 6X; Bellis perennis 6X; Calendula officinalis 6X; Hamamelis virginiana 6X; Hypericum perforatum 6X; Ledum palustre 6X; Ruta graveolens 6X; Symphytum officinale 6X


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of: • Pain • Headache • General fatigue • Back pain

Dosage and Administration (34068-7)

Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times daily or as directed by a physician. If symptoms persist, take 1 tablet every 30 minutes; not to exceed 12 tablets daily.

Warnings and Precautions (34071-1)

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . If symptoms persist or worsen, a health professional should be consulted. Do not use if sensitivity to Pain & Injury Relief or any of its ingredients exists. In case of accidental overdose, contact a poison control center immediately.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

Lactose, Magnesium stearate

Section 51945-4 (51945-4)

Add image transcription here...

Section 55105-1 (55105-1)

Pain & Injury Relief

Section 55106-9 (55106-9)

Each tablet contains equal parts of Aconitum napellus 4X; Arnica montana, radix 6X; Bellis perennis 6X; Calendula officinalis 6X; Hamamelis virginiana 6X; Hypericum perforatum 6X; Ledum palustre 6X; Ruta graveolens 6X; Symphytum officinale 6X


Raw Label Data

All Sections (JSON)