Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID a7e428d3-9460-48d0-9c8d-1e8846bec857
Route
ORAL
Published
Effective Date 2024-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Chamomilla (4 [hp_X]) Arabica Coffee Bean (6 [hp_X]) Avena Sativa Flowering Top Strychnos Nux-vomica Seed Passiflora Incarnata Flowering Top
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-06-19

Description

Chamomilla 4X, Coffea Cruda 4X, Avena Sativa 6X, Nux Vomica 6X, Passiflora Incarnata 6X.

Purpose

Avena Sativa – For sleeplessness, Chamomilla – For irritability, sleeplessness, and restlessness, Coffea Cruda – For sleeplessness when the mind is awake, Nux Vomica- For those who awake early and cannot get back to sleep, Passiflora Incarnata – For restlessness due to exhaustion.


Medication Information

Purpose

Avena Sativa – For sleeplessness, Chamomilla – For irritability, sleeplessness, and restlessness, Coffea Cruda – For sleeplessness when the mind is awake, Nux Vomica- For those who awake early and cannot get back to sleep, Passiflora Incarnata – For restlessness due to exhaustion.

Description

Chamomilla 4X, Coffea Cruda 4X, Avena Sativa 6X, Nux Vomica 6X, Passiflora Incarnata 6X.

Uses:

Nighttime sleep aid

Section 51727-6

Lactose, Magnesium Stearate, Microcrystaline Cellulose.

Purpose:

Avena Sativa – For sleeplessness, Chamomilla – For irritability, sleeplessness, and restlessness, Coffea Cruda – For sleeplessness when the mind is awake, Nux Vomica- For those who awake early and cannot get back to sleep, Passiflora Incarnata – For restlessness due to exhaustion.

Warnings:



If pregnant or breastfeeding, ask a health professional before use.

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

Questions:

Dist. by:

The Magni Group, Inc.

McKinney, TX 75071 USA

www.magnilife.com

1-800-645-9199

Directions:

• Adults and children 12 years and above, dissolve 1 to 3 tablets under tongue 1/2 to 1 hour before bedtime.

• Children under 12 years, consult a physician.

Other Information:

Store tightly closed in a dry place

• Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing

• The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United

States

• These statements are supported by the traditional homeopathic principles

Active Ingredients:

Chamomilla 4X, Coffea Cruda 4X, Avena Sativa 6X, Nux Vomica 6X, Passiflora Incarnata 6X.

Package Label Display:

MAGNILIFE®         HOMEOPATHIC 

SLEEP ASSIST       NDC 43689-0018-1

For sleeplessness and

difficulty falling asleep

125 Tablets

Keep Out of Reach of Children:

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


Structured Label Content

Uses: (USES:)

Nighttime sleep aid

Section 51727-6 (51727-6)

Lactose, Magnesium Stearate, Microcrystaline Cellulose.

Purpose: (PURPOSE:)

Avena Sativa – For sleeplessness, Chamomilla – For irritability, sleeplessness, and restlessness, Coffea Cruda – For sleeplessness when the mind is awake, Nux Vomica- For those who awake early and cannot get back to sleep, Passiflora Incarnata – For restlessness due to exhaustion.

Warnings: (WARNINGS:)



If pregnant or breastfeeding, ask a health professional before use.

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

Questions: (QUESTIONS:)

Dist. by:

The Magni Group, Inc.

McKinney, TX 75071 USA

www.magnilife.com

1-800-645-9199

Directions: (DIRECTIONS:)

• Adults and children 12 years and above, dissolve 1 to 3 tablets under tongue 1/2 to 1 hour before bedtime.

• Children under 12 years, consult a physician.

Other Information: (OTHER INFORMATION:)

Store tightly closed in a dry place

• Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing

• The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United

States

• These statements are supported by the traditional homeopathic principles

Active Ingredients: (ACTIVE INGREDIENTS:)

Chamomilla 4X, Coffea Cruda 4X, Avena Sativa 6X, Nux Vomica 6X, Passiflora Incarnata 6X.

Package Label Display: (PACKAGE LABEL DISPLAY:)

MAGNILIFE®         HOMEOPATHIC 

SLEEP ASSIST       NDC 43689-0018-1

For sleeplessness and

difficulty falling asleep

125 Tablets

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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