Label at a glance#

ProductBackache Relief

Active ingredientARNICA MONTANA, BELLIS PERENNIS, ACONITUM NAPELLUS, BRYONIA ALBA ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF

Label structure10 sections

Indications and uses

■ Temporarily relieves backache pain

Dosage and administration

■ 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.

Contacts and useful links#

Websitewww.hylands.com

www.hylands.com

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Backache Relief

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

*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.

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves backache pain

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ pain gets worse or lasts more than 7 days.
■ new symptoms occur.
■ redness or swelling is present

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions?

OTC - QUESTIONS SECTION

www.hylands.com or care@hylands.com

Dosage and Administration

RECENT MAJOR CHANGES SECTION

(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.

Indications and Usage

RECENT MAJOR CHANGES SECTION

Uses

■ Helps temporarily relieve backache pain

Removed "Helps"

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-4011-1

100 TABLETS

labelcarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54973-4011-1	Backache Relief	1 in 1 CARTON	TABLET	1		4
54973-4011-1	Backache Relief	100 in 1 BOTTLE	TABLET	100		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-4011	BACKACHE RELIEF (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, BELLIS PERENNIS, TOXICODENDRON PUBESCENS LEAF AND ARNICA MONTANA) TABLET [HYLAND'S INC.]	4	Current NDC, Legacy NDC, 2 package rows	20230511_a51452b3-0aba-6928-e053-2995a90a1619.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Backache Relief
Aconitum Napellus, Bryonia Alba Root, Magnesium Phosphate, Dibasic Trihydrate, Bellis Perennis, Toxicodendron Pubescens Leaf and Arnica Montana
LACTOSE MONOHYDRATE
ACACIA
ARNICA MONTANA
BELLIS PERENNIS
ACONITUM NAPELLUS
BRYONIA ALBA ROOT
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
MAGNESIUM CATION
TOXICODENDRON PUBESCENS LEAF

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-4011	54973-4011-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
ACACIA	5C5403N26O	IACT
ARNICA MONTANA	O80TY208ZW	ACTIB
BELLIS PERENNIS	2HU33I03UY	ACTIB
ACONITUM NAPELLUS	U0NQ8555JD	ACTIB
BRYONIA ALBA ROOT	T7J046YI2B	ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	HF539G9L3Q	ACTIB
TOXICODENDRON PUBESCENS LEAF	6IO182RP7A	ACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Backache Relief	ACONITUM NAPELLUS, BRYONIA ALBA ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, BELLIS PERENNIS, TOXICODENDRON PUBESCENS LEAF AND ARNICA MONTANA	Hyland's Inc.	a51452b3-0aba-6928-e053-2995a90a1619	2023-05-10	Warnings	Exact identifier ndc (package): 54973-4011-1 ndc (product): 54973-4011 ndc11 (package): 54973401101 spl id: fb5962be-5af1-206f-e053-6294a90aa8b0 spl set id: a51452b3-0aba-6928-e053-2995a90a1619

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.