Restful Legs PM: Homeopathic Product Information

RESTFUL LEGS PM- arsenic trioxide, matricaria chamomilla, sulfur, zinc, arabica coffee bean, lycopodium clavatum spore, pulsatilla patens whole and toxicodendron pubescens leaf tablet
Hyland’s Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Facts

Active Ingredients

Arsenicum Album 12X HPUS

Chamomilla 3X HPUS

Coffea Cruda 3X HPUS

Lycopodium 6X HPUS

Pulsatilla 6X HPUS

Rhus Toxicodendron 6X HPUS

Sulphur 6X HPUS

Zincum Metallicum 12X HPUS

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Purpose

creeping, crawling itch

occasional sleeplessness, disrupted sleep

occasional sleeplessness

feeling of agitation while lying down

constant urge to move legs

agitation, better with activity

itching, tingling, and urge to move legs

twitching and jerking of legs while sitting

Uses

■ Helps temporarily relieve occasional sleeplessness or disrupted sleep due to:

■ agitation or compelling urge to jerk or move legs

■ itching, tingling, or crawling sensations in legs

Warnings

Ask a doctor before use if you have

Restless Leg Syndrome.

Stop use and ask a doctor if

symptoms persist for more than 7 days or worsen.

If pregnant or breastfeeding

Ask a health professional before use

Keep out of reach of children

Directions

■ Use as directed.

Adults and Children 12 years and over	Dissolve 2-3 tablets under tongue at bedtime and every 4 hours during the night until relieved.
Children 6 years to under 12 years	Dissolve 1-2 tablets under tongue at bedtime and every 4 hours during the night until relieved.

Inactive Ingredients

Acacia Gum, Lactose.

Questions?

www.hylands.com or care@hylands.com

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**THIS PRODUCT IS NOT INTENDED TO TREAT RESTLESS LEG SYNDROME.

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Principal Display Panel

Hyland’s

^NATURALS™

RESTFUL

LEGS PM

FAST + EFFECTIVE RELIEF*

Helps calm

agitated legs

so you can sleep**

50

^{QUICK-DISSOLVING}

^TABLETS

HOMEOPATHIC

RESTFUL LEGS PM anemone patens,matricaria chamomilla,sulfur,zinc,toxicodendron pubescens leaf,arsenic trioxide,arabica coffee bean,lycopodium clavatum spore tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3352 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 12 [hp_X] MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 3 [hp_X] SULFUR (SULFUR) SULFUR 6 [hp_X] ZINC (ZINC) ZINC 12 [hp_X] ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 3 [hp_X] LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 6 [hp_X] PULSATILLA PATENS WHOLE (PULSATILLA PATENS WHOLE) PULSATILLA PATENS WHOLE 6 [hp_X] TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 6 [hp_X]

Inactive Ingredients Ingredient Name Strength ACACIA LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE)

Product Characteristics Color white (Off-White to Light Beige) Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54973-3352-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 50 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3352-1) 2 NDC:54973-3352-2 4 TABLET in 1 PACKET None 3 NDC:54973-3352-3 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 3 30 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3352-3) 4 NDC:54973-3352-4 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 4 16 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3352-4) 5 NDC:54973-3352-5 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 5 16 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3352-5)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/14/2018

Labeler — Hyland’s Inc. (008316655)

Establishment
Name	Address	ID/FEI	Operations
Hyland’s Consumer Health Inc.		008316655	pack (54973-3352), label (54973-3352), manufacture (54973-3352)

Revised: 11/2022 Hyland’s Inc.