Hyland's Naturals Backache Relief

SPL v4

SPL

SPL Set ID a51452b3-0aba-6928-e053-2995a90a1619

Route

ORAL

Published

Effective Date 2023-04-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Arnica Montana (6 [hp_X]) Bellis Perennis Aconitum Napellus Bryonia Alba Root Magnesium Cation Toxicodendron Pubescens Leaf

Inactive Ingredients

Lactose Monohydrate Acacia

Identifiers & Packaging

Pill Appearance

Shape: round Color: white Size: 9 mm Score: 1

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2020-03-30

Description

Backache Relief

Indications and Usage

Uses ■ Helps temporarily relieve backache pain Removed "Helps"

Dosage and Administration

(Directions) ■ Use as directed Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. Children under 12 years of age Ask a doctor before use.

Medication Information

Indications and Usage

Uses

■ Helps temporarily relieve backache pain

Removed "Helps"

Dosage and Administration

(Directions)

■ Use as directed

Adults and children 12 years and over	At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved.
Children under 12 years of age	Ask a doctor before use.

Description

Backache Relief

Uses

■ Temporarily relieves backache pain

Section 55105-1

Backache Relief

Directions

■ Use as directed.

Adults and children

12 years and over

At onset of symptoms, dissolve 2 tablets under tongue every

15 minutes up to 4 doses. If symptoms persist, 2 tablets every

4 hours until relieved.

Children under

12 years of age

Ask a doctor before use.

Questions?

www.hylands.com or [email protected]

Active Ingredients

Active ingredients	Purpose
Aconitum Napellus 6X HPUS	backache pain
Arnica Montana 6X HPUS	backache pain
Bellis Perennis 6X HPUS	backache pain
Bryonia Alba 6X HPUS	backache pain
Magnesia Phosphorica 6X HPUS	backache pain
Rhus Toxicodendron 6X HPUS	backache pain

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Inactive Ingredients

Acacia Gum, Lactose.

Principal Display Panel

NDC 54973-4011-1

100 TABLETS

If Pregnant Or Breastfeeding

Ask a health professional before use.

Stop Use and Ask A Doctor If

■ pain gets worse or lasts more than 7 days.

■ new symptoms occur.

■ redness or swelling is present

Do Not Use If Tamper Evident Seal Is Broken Or Missing.

Structured Label Content

Uses

■ Temporarily relieves backache pain

Section 55105-1 (55105-1)

Backache Relief

Directions

■ Use as directed.

Adults and children

12 years and over

At onset of symptoms, dissolve 2 tablets under tongue every

15 minutes up to 4 doses. If symptoms persist, 2 tablets every

4 hours until relieved.

Children under

12 years of age

Ask a doctor before use.

Questions?

www.hylands.com or [email protected]

Active Ingredients (Active ingredients)

Active ingredients	Purpose
Aconitum Napellus 6X HPUS	backache pain
Arnica Montana 6X HPUS	backache pain
Bellis Perennis 6X HPUS	backache pain
Bryonia Alba 6X HPUS	backache pain
Magnesia Phosphorica 6X HPUS	backache pain
Rhus Toxicodendron 6X HPUS	backache pain

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Inactive Ingredients (Inactive ingredients)

Acacia Gum, Lactose.

Indications and Usage

Uses

■ Helps temporarily relieve backache pain

Removed "Helps"

Principal Display Panel

NDC 54973-4011-1

100 TABLETS

Dosage and Administration

(Directions)

■ Use as directed

Adults and children 12 years and over	At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved.
Children under 12 years of age	Ask a doctor before use.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

Ask a health professional before use.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ pain gets worse or lasts more than 7 days.

■ new symptoms occur.

■ redness or swelling is present

Do Not Use If Tamper Evident Seal Is Broken Or Missing. (DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.)

Advanced Ingredient Data

[{"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA", "unii": "O80TY208ZW", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "BELLIS PERENNIS", "unii": "2HU33I03UY", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "ACONITUM NAPELLUS", "unii": "U0NQ8555JD", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "BRYONIA ALBA ROOT", "unii": "T7J046YI2B", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM CATION", "unii": "T6V3LHY838", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "TOXICODENDRON PUBESCENS LEAF", "unii": "6IO182RP7A", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "■ Temporarily relieves backache pain", "55105-1": "Backache Relief", "Directions": "■ Use as directed. Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. Children under 12 years of age Ask a doctor before use.", "Questions?": "www.hylands.com or care@hylands.com", "Active ingredients": "Active ingredients Purpose Aconitum Napellus 6X HPUS backache pain Arnica Montana 6X HPUS backache pain Bellis Perennis 6X HPUS backache pain Bryonia Alba 6X HPUS backache pain Magnesia Phosphorica 6X HPUS backache pain Rhus Toxicodendron 6X HPUS backache pain "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.", "Inactive ingredients": "Acacia Gum, Lactose.", "Indications and Usage": "Uses ■ Helps temporarily relieve backache pain Removed "Helps"", "Principal Display Panel": "NDC 54973-4011-1 100 TABLETS", "Dosage and Administration": "(Directions) ■ Use as directed Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. Children under 12 years of age Ask a doctor before use.", "If pregnant or breastfeeding": "Ask a health professional before use.", "Stop use and ask a doctor if": "■ pain gets worse or lasts more than 7 days. ■ new symptoms occur. ■ redness or swelling is present"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:06.538161 · Updated: 2026-03-14T23:16:11.265720