Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 2dc9026a-b847-403b-a92e-5d629e4b3c68
Route
ORAL
Published
Effective Date 2017-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arsenic Cation (3+) (30 [hp_X]) Avena Sativa Flowering Top Arabica Coffee Bean Carbonate Ion Strychnos Nux-vomica Seed Passiflora Incarnata Flowering Top Sepia Officinalis Juice Valerian
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-10-24

Description

Arsenicum Album 30X, Avena Sativa 30X, Coffea Cruda 30X, Kali Carbonicum 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X.


Medication Information

Description

Arsenicum Album 30X, Avena Sativa 30X, Coffea Cruda 30X, Kali Carbonicum 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X.

Warnings:

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

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

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

Questions:

Distributed by:

Guangzhou Renuma Medical

Systems Co., Ltd.

No. 5, 2nd Floor, Ascendas 2nd Street

Sino-Singapore Guangzhou Knowledge City

Guangzhou 510555, China

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve symptoms due to fatigue and restlessness from inability to sleep.

Active Ingredients:

Arsenicum Album 30X, Avena Sativa 30X, Coffea Cruda 30X, Kali Carbonicum 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X.

Inactive Ingredients:

Demineralized water, Glycerin

Package Label Display:

SLEEP WELL

T012

HOMEOPATHIC

2 fl. oz. (59 ml)

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.


Structured Label Content

Warnings: (WARNINGS:)

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

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

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

Questions: (QUESTIONS:)

Distributed by:

Guangzhou Renuma Medical

Systems Co., Ltd.

No. 5, 2nd Floor, Ascendas 2nd Street

Sino-Singapore Guangzhou Knowledge City

Guangzhou 510555, China

Directions: (DIRECTIONS:)

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

May temporarily relieve symptoms due to fatigue and restlessness from inability to sleep.

Active Ingredients: (ACTIVE INGREDIENTS:)

Arsenicum Album 30X, Avena Sativa 30X, Coffea Cruda 30X, Kali Carbonicum 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, Glycerin

Package Label Display: (PACKAGE LABEL DISPLAY:)

SLEEP WELL

T012

HOMEOPATHIC

2 fl. oz. (59 ml)

Keep Out of Reach of Children: (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.


Advanced Ingredient Data


Raw Label Data

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