HYLANDS LEG CRAMPS WITH ARNICA- aconitum napellus tablet

Hylands Leg Cramps With Arnica by

Drug Labeling and Warnings

Hylands Leg Cramps With Arnica by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Consumer Health Inc., Hyland's Consumer Health INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Homeopathic claims

*CLAIMS BASED ON TRADITIONAL HOMEOPATHICPRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.

DRUG FACTS

Drug Facts

Active Ingredients

ACONITUM NAPELLUS 5X HPUS

ARNICA MONTANA 5X HPUS

CINCHONA OFFICINALIS 2X HPUS

GNAPHALIUM POLYCEPHALIUM 2X HPUS

LEDUM PAULSTRE 5X HPUS

MAGNESIA PHOSPHORICA 5X HPUS

RHUS TOXICODENDRON 5X HPUS

"HPUS" is the Homeopathic Pharmacopeia of the United States

Purpose*

Pain in joints and legs

Leg muscle soreness and pain

Cramping in legs

Cramps in calves and feet

Pain and cramps in legs

Muscle cramps

Pain and stiffness

Uses*

Helps temporarily relieve symptoms of:

• Stiffness
• Pain in joints or legs
• Cramps in calves, feet or legs
• Residuall muscle soreness

Directions

Use as directed

Adults and children 12 and over:

At onset of symptoms, swallow 1-2 caplets with water every 4 hours as needed. If the initial dosage is not providing immediate relief, swallow 1-2 caplets with water every 30 minutes until relieved, up to 6 doses.

Children under 12 years of age:

Ask a doctor beofre use

Inactive ingredients

Lactose, Magnesium Stearate, Microcrystalline Cellulose

Questions?

www.hylands.com or care@hylands.com

DOSAGE & ADMINISTRATION

Oral

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

WARNINGS

ASK A DOCTOR BEFORE USE IF:

SENSITIVE TO QUININE

PREGNANT OR BREASTFEEDING

PRINCIPAL DISPLAY PANEL

Hylands Naturals

Leg Cramps*

+Arnica

Helps relieve leg

cramps and residual soreness

100

caplets

[product image]

Homeopathic

INGREDIENTS AND APPEARANCE

HYLANDS LEG CRAMPS WITH ARNICA 
aconitum napellus tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4126
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	5 [hp_X]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	5 [hp_X]
CINCHONA BARK (UNII: 292E43P4I9) (CINCHONA BARK - UNII:292E43P4I9)	CINCHONA BARK	2 [hp_X]
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW)	PSEUDOGNAPHALIUM OBTUSIFOLIUM	2 [hp_X]
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	2 [hp_X]
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	5 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4126-1	100 in 1 CARTON; Type 0: Not a Combination Product	03/21/2024
2	NDC: 54973-4126-2	40 in 1 CARTON; Type 0: Not a Combination Product	03/21/2024
3	NDC: 54973-4126-3	16 in 1 CARTON; Type 0: Not a Combination Product	03/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/21/2024

Labeler - Hyland's Consumer Health Inc. (008316655)

Establishment
Name	Address	ID/FEI	Business Operations
Hyland's Consumer Health INC.		008316655	manufacture(54973-4126) , pack(54973-4126) , label(54973-4126)