Backache With Arnica (Benzoic Acid, Colchicum Autumnale Bulb, Sulfur, Arnica Montana, And Toxicodendron Pubescens Leaf) Tablet, Soluble [Hyland's] -

BACKACHE WITH ARNICA (BENZOIC ACID, COLCHICUM AUTUMNALE BULB, SULFUR, ARNICA MONTANA, AND TOXICODENDRON PUBESCENS LEAF) TABLET, SOLUBLE [HYLAND'S]
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NDC	54973-2965-1
Set ID	f25f2a26-bddf-49bb-b1bc-084ce86f00cb
Category	HUMAN OTC DRUG LABEL
Packager	Hyland's
Generic Name
Product Class
Product Number
Application Number

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PURPOSE

Hyland's ® BackAche is a traditional homeopathic formula for the relief of symptoms of pains in the lower back due to strain, overexertion, cold or exposure. Hyland's BackAche contains Arnica Montana which is the most commonly used homeopathic medicine for relief of muscular pain. Hyland's BackAche works without contraindications or side effects to relieve symptoms naturally. This product is a gentle, safe medication that may be used in conjunction with other medications.
Indications

A homeopathic medicine for the temporary relief of symptoms of low back pain due to strain or overexertion.
Directions

For adults and children over 12 years of age: Dissolve 2-3 tablets under the tongue every 4 hours or as needed.
ACTIVE INGREDIENT

FORMULA

BENZOICUM ACIDUM 3X HPUS, COLCHICUM AUTUMNALE 3X HPUS, SULPHUR 3X HPUS, ARNICA MONTANA 6X HPUS, RHUS TOXICODENDRON 6X HPUS IN A BASE OF LACTOSE, N.F.
Warnings

Do not use if imprinted cap band is broken or missing.

If symptoms persist for more than 7 days or worsen, consult a licensed health care professional.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a licensed health care professional before using this product.

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a poison control center immediately. In case of emergency, the manufacturer may be reached 24 hours a day, 7 days a week at 800/624-9659.
SPL UNCLASSIFIED SECTION

HYLAND'S INC.
LOS ANGELES, CA 90061
QUESTIONS?

CALL US: 800/624-9659
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

NDC 54973-2965-1

Hyland's®
HOMEOPATHIC

BACKACHE
WITH ARNICA

Fast Symptomatic Relief
for Low Back Pain.

100
TABLETS

INGREDIENTS AND APPEARANCE

BACKACHE WITH ARNICA
benzoic acid, colchicum autumnale bulb, sulfur, arnica montana, and toxicodendron pubescens leaf tablet, soluble

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-2965
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM)	BENZOIC ACID	3 [hp_X]
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	3 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-2965-1	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/15/1999

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/15/1999

Labeler - Hyland's (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-2965)

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Medic

BACKACHE WITH ARNICA (BENZOIC ACID, COLCHICUM AUTUMNALE BULB, SULFUR, ARNICA MONTANA, AND TOXICODENDRON PUBESCENS LEAF) TABLET, SOLUBLE [HYLAND'S]

FORMULA

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