RESTULEX (bufo rana, causticum, chamomilla, crotalus horridus, digitalis purpurea, lachesis mutus, lilium tigrinum, pulsatilla- pratensis rhus tox, sulphur, tarentula hispana, viscum album, zincum metallicum. tablet

Restulex by

Drug Labeling and Warnings

Restulex by is a Homeopathic medication manufactured, distributed, or labeled by HelloLife, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE HPUS INGREDIENTS:

Bufo Rana 10X, 30X, 200C, Causticum 10X, 30X, 200C, Chamomilla 10X, 30X, 200C, Crotalus Horridus 10X, 30X, 200C, Digitalis Purpurea 10X, 30X, 200C, Lachesis Mutus 10X, 30X, 200C, Lilium Tigrinum 10X, 30X, 200C, Pulsatilla (Pratensis) 10X, 30X, 200C, Rhus Tox 10X, 30X, 200C, Sulphur 10X, 30X, 200C, Tarentula Hispana 10X, 30X, 200C, Viscum Album 10X, 30X, 200C, Zincum Metallicum 10X, 30X, 200C.

INDICATIONS FOR USE:

For the temporary relief of symptoms such as:

twitching 

burning

heaviness

jerking

cramping

pain

Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

WARNINGS:

Stop use and as a doctor if symptoms persist or worsen.

If pregnant or breast-feeding, ask health professional before use.

Do not use if tamper seal is broken.

STORAGE & HANDLING:

Do not store next to electrical devices or appliances.

Keep lid tightly closed & store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Dissolve under tongue.

30-50lb (13.6kg-22.6kg): twice daily.

50lb+ (22.6kg): 1 tablet twice daily.

INDICATIONS FOR USE:

For the temporary relief of symptoms such as:

twitching

burning

heaviness

jerking

cramping

pain

Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

INACTIVE INGREDIENTS:

Copovidone, Crospovidone, Lactose, Magnesium, Stearate, Mannitol, Microcrystalline, Cellulose, Silicon Dioxide, Sorbitol.

QUESTIONS:

Dist. by: HelloLife, Inc.

4635 40th St SE

Grand Rapids, MI 49512

www.hellolife.net

PACKAGE LABEL DISPLAY:

NDC: 49726-047-60
RESTULEX
TABLETS
Natural Relief for 
Restless Leg Symptoms
Homeopathic (OTC) Medicine
60 Quick-dissolving Tablets

INGREDIENTS AND APPEARANCE

RESTULEX 
bufo rana, causticum, chamomilla, crotalus horridus, digitalis purpurea, lachesis mutus, lilium tigrinum, pulsatilla (pratensis) rhus tox, sulphur, tarentula hispana, viscum album, zincum metallicum. tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49726-047
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q)	BUFO BUFO CUTANEOUS GLAND	10 [hp_X]
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	10 [hp_X]
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	10 [hp_X]
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956)	CROTALUS HORRIDUS HORRIDUS VENOM	10 [hp_X]
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	10 [hp_X]
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	10 [hp_X]
LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI)	LILIUM LANCIFOLIUM WHOLE FLOWERING	10 [hp_X]
ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI)	ANEMONE PRATENSIS	10 [hp_X]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	10 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 [hp_X]
LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT)	LYCOSA TARANTULA	10 [hp_X]
VISCUM ALBUM FRUIT (UNII: P83EQ521R3) (VISCUM ALBUM FRUIT - UNII:P83EQ521R3)	VISCUM ALBUM FRUIT	10 [hp_X]
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	10 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
COPOVIDONE K25-31 (UNII: D9C330MD8B)
CROSPOVIDONE (UNII: 2S7830E561)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49726-047-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/10/2019

Labeler - HelloLife, Inc. (065619378)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(49726-047) , api manufacture(49726-047) , label(49726-047) , pack(49726-047)