Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 3f62001a-27b5-43cb-8006-110943facf87
Route
ORAL
Published
Effective Date 2016-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna (12 [hp_X]) Oyster Shell Calcium Carbonate, Crude Matricaria Chamomilla Calcium Sulfide Dichromate Ion Lycopodium Clavatum Spore Plantago Major Anemone Pulsatilla
Inactive Ingredients
Lactose Magnesium Stearate Cellulose, Microcrystalline

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-05-09

Description

Belladonna 12X, Calcarea Carbonica 12X, Chamomilla 12X, Hepar Sulphuris Calcareum 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Plantago Major 12X, Pulsatilla (Vulgaris) 12X.


Medication Information

Description

Belladonna 12X, Calcarea Carbonica 12X, Chamomilla 12X, Hepar Sulphuris Calcareum 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Plantago Major 12X, Pulsatilla (Vulgaris) 12X.

Uses:

For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

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.

• Stop use and ask a doctor if you experience worsening symptoms or if symptoms last longer than 7 days.

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 1-2 tablets under tongue, 2 to 3 times daily or as directed by a physician.

Children under 12 years, consult a physician.

Indications:

For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

Other Information:

• Store tightly closed in a cool, dry place (59° - 86°F)

• 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:

Belladonna 12X, Calcarea Carbonica 12X, Chamomilla 12X, Hepar Sulphuris Calcareum 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Plantago Major 12X, Pulsatilla (Vulgaris) 12X.

Inactive Ingredients:

Lactose, Magnesium Stearate, Microcrystalline Cellulose

Package Label Display:

MAGNILIFE Homeopathic

NDC 43689-0020-1

EARACHE RELIEF

Targets ear pain

for fast relief

Soothes ear pain and

discomfort due to:

√ Allergy

√ Cold & Flu

√ Congestion

√Swimmer's Ear

90 Dissolving 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.


Structured Label Content

Uses: (USES:)

For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

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.

• Stop use and ask a doctor if you experience worsening symptoms or if symptoms last longer than 7 days.

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 1-2 tablets under tongue, 2 to 3 times daily or as directed by a physician.

Children under 12 years, consult a physician.

Indications: (INDICATIONS:)

For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

Other Information: (OTHER INFORMATION:)

• Store tightly closed in a cool, dry place (59° - 86°F)

• 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:)

Belladonna 12X, Calcarea Carbonica 12X, Chamomilla 12X, Hepar Sulphuris Calcareum 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Plantago Major 12X, Pulsatilla (Vulgaris) 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Lactose, Magnesium Stearate, Microcrystalline Cellulose

Package Label Display: (PACKAGE LABEL DISPLAY:)

MAGNILIFE Homeopathic

NDC 43689-0020-1

EARACHE RELIEF

Targets ear pain

for fast relief

Soothes ear pain and

discomfort due to:

√ Allergy

√ Cold & Flu

√ Congestion

√Swimmer's Ear

90 Dissolving Tablets

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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