Drug Facts:

Drug Facts:
SPL v13
SPL
SPL Set ID ec5bc7e7-4be6-45a6-8cd9-62fdfa7fb469
Route
ORAL
Published
Effective Date 2025-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phosphoric Acid (6 [hp_X]) Aluminum Hydroxide (9 [hp_X]) Phosphorus (12 [hp_X]) Polygala Senega Root (13 [hp_X]) Adenosine Cyclic Phosphate (15 [hp_X]) Antimony Cation (3+) (18 [hp_X]) Grindelia Hirsutula Flowering Top (12 [hp_C]) Schoenocaulon Officinale Seed Aluminum Oxide Copper Nitrate Ion Silicon Dioxide Lachesis Muta Venom Rheum Palmatum Root Zinc Lycopodium Clavatum Spore Manganese Cation (2+) Antipyrine Coenzyme A
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-05-18

Description

Adenosinum Cyclophosphoricum 9X, 30C, 200C HPUS, Alumen 6X, 30C, 200C HPUS, Alumina 12X, 30C HPUS, Antimonium Tartaricum 9X, 30C, 200C HPUS, Antipyrinum 18X, 30C, 200C HPUS, Coenzyme A 12C, 30C, 200C HPUS, Cuprum Metallicum 12X, 30C HPUS, Grindelia 9X, 30C, 200C HPUS, Lachesis Mutus 12X, 30C, 200C HPUS, Lycopodium Clavatum 13X, 200C HPUS, Manganum Phosphoricum 15X, 30C HPUS, Phosphoricum Acidum 6X, 30C HPUS, Phosphorus 9X, 30C HPUS, Rheum (Palmatum) 12X, 30C, 200C HPUS, Sabadilla 9X, 30C, 200C HPUS, Sanguinarinum Nitricum 12X, 30C HPUS, Senega Officinalis 9X, 30C HPUS, Silicea 12X, 30C HPUS, Zincum Metallicum 12X, 30C, 200C HPUS.

Purpose

Adenosinum Cyclophosphoricum – For temporary relief of insomnia, Alumen – For temporary relief of throat pain, Alumina – For temporary relief of fatigue, Antimonium Tartaricum – For temporary relief of dry mouth, Antipyrinum – For temporary relief of fatigue, Coenzyme A – For energy, Cuprum Metallicum – For temporary relief of dry mouth, Grindelia – For temporary relief of eye pain, Lachesis Mutus – For temporary relief of disordered sleep, Lycopodium Clavatum – For temporary relief of abnormal sleep, Manganum Phosphoricum – For temporary relief of sore throat, Phosphoricum Acidum – For temporary relief of debility, Phosphorus – For temporary relief of sleep disturbance, Rheum (Palmatum) – For temporary relief of dizziness, Sabadilla – For temporary relief of allergy, Sanguinarinum Nitricum – For temporary relief of nasal drip, Senega Officinalis – For temporary relief of cough, Silicea – For temporary relief of body ache, Zincum Metallicum – For temporary relief of weak memory


Medication Information

Purpose

Adenosinum Cyclophosphoricum – For temporary relief of insomnia, Alumen – For temporary relief of throat pain, Alumina – For temporary relief of fatigue, Antimonium Tartaricum – For temporary relief of dry mouth, Antipyrinum – For temporary relief of fatigue, Coenzyme A – For energy, Cuprum Metallicum – For temporary relief of dry mouth, Grindelia – For temporary relief of eye pain, Lachesis Mutus – For temporary relief of disordered sleep, Lycopodium Clavatum – For temporary relief of abnormal sleep, Manganum Phosphoricum – For temporary relief of sore throat, Phosphoricum Acidum – For temporary relief of debility, Phosphorus – For temporary relief of sleep disturbance, Rheum (Palmatum) – For temporary relief of dizziness, Sabadilla – For temporary relief of allergy, Sanguinarinum Nitricum – For temporary relief of nasal drip, Senega Officinalis – For temporary relief of cough, Silicea – For temporary relief of body ache, Zincum Metallicum – For temporary relief of weak memory

Description

Adenosinum Cyclophosphoricum 9X, 30C, 200C HPUS, Alumen 6X, 30C, 200C HPUS, Alumina 12X, 30C HPUS, Antimonium Tartaricum 9X, 30C, 200C HPUS, Antipyrinum 18X, 30C, 200C HPUS, Coenzyme A 12C, 30C, 200C HPUS, Cuprum Metallicum 12X, 30C HPUS, Grindelia 9X, 30C, 200C HPUS, Lachesis Mutus 12X, 30C, 200C HPUS, Lycopodium Clavatum 13X, 200C HPUS, Manganum Phosphoricum 15X, 30C HPUS, Phosphoricum Acidum 6X, 30C HPUS, Phosphorus 9X, 30C HPUS, Rheum (Palmatum) 12X, 30C, 200C HPUS, Sabadilla 9X, 30C, 200C HPUS, Sanguinarinum Nitricum 12X, 30C HPUS, Senega Officinalis 9X, 30C HPUS, Silicea 12X, 30C HPUS, Zincum Metallicum 12X, 30C, 200C HPUS.

Uses:

Temporarily alleviates symptoms of sleep disorders.

These "uses" have not been evaluated by the Food and Drug Administration.

Purpose:

Adenosinum Cyclophosphoricum – For temporary relief of insomnia, Alumen – For temporary relief of throat pain, Alumina – For temporary relief of fatigue, Antimonium Tartaricum – For temporary relief of dry mouth, Antipyrinum – For temporary relief of fatigue, Coenzyme A – For energy, Cuprum Metallicum – For temporary relief of dry mouth, Grindelia – For temporary relief of eye pain, Lachesis Mutus – For temporary relief of disordered sleep, Lycopodium Clavatum – For temporary relief of abnormal sleep, Manganum Phosphoricum – For temporary relief of sore throat, Phosphoricum Acidum – For temporary relief of debility, Phosphorus – For temporary relief of sleep disturbance, Rheum (Palmatum) – For temporary relief of dizziness, Sabadilla – For temporary relief of allergy, Sanguinarinum Nitricum – For temporary relief of nasal drip, Senega Officinalis – For temporary relief of cough, Silicea – For temporary relief of body ache, Zincum Metallicum – For temporary relief of weak memory

Warnings:

As with any drug, ask a doctor before use if pregnant or nursing. Warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physicians promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

Keep this and all medications out of the reach of children.

In case of accidental overdose, contact a medical professional or poison control center immediately.

Questions:

Call weekdays 9am-5pm (918)791-1727

Distributed by:

Nucleic Products, LLC

PO Box 7148 Grove, OK 74344

Directions:

Adults and Children 12 years of age and older: Take one full eyedropper twice a day to help alleviate symptoms of sleep disorders. Under 12 years of age: Consult a physician.

Other Information:

Do not use if seal is broken or missing. This product does not contain sugar, starch, preservatives, artificial flavors or additives, and no wheat, gluten, soy, or milk derivatives.

Active Ingredients:

Adenosinum Cyclophosphoricum 9X, 30C, 200C HPUS, Alumen 6X, 30C, 200C HPUS, Alumina 12X, 30C HPUS, Antimonium Tartaricum 9X, 30C, 200C HPUS, Antipyrinum 18X, 30C, 200C HPUS, Coenzyme A 12C, 30C, 200C HPUS, Cuprum Metallicum 12X, 30C HPUS, Grindelia 9X, 30C, 200C HPUS, Lachesis Mutus 12X, 30C, 200C HPUS, Lycopodium Clavatum 13X, 200C HPUS, Manganum Phosphoricum 15X, 30C HPUS, Phosphoricum Acidum 6X, 30C HPUS, Phosphorus 9X, 30C HPUS, Rheum (Palmatum) 12X, 30C, 200C HPUS, Sabadilla 9X, 30C, 200C HPUS, Sanguinarinum Nitricum 12X, 30C HPUS, Senega Officinalis 9X, 30C HPUS, Silicea 12X, 30C HPUS, Zincum Metallicum 12X, 30C, 200C HPUS.

Inactive Ingredients:

20% organic ethanol, purified water

Packaging Label Display:

NDC: 75053-0008-1

Nu cleic

Apnetem

Temperare Regulation Series

Homeopathic Medicine

For Professional Use Only

4 fl oz. (118 ml)

Keep Out of Reach of Children:

In case of accidental overdose, contact a medical professional or poison control center immediately.


Structured Label Content

Uses: (USES:)

Temporarily alleviates symptoms of sleep disorders.

These "uses" have not been evaluated by the Food and Drug Administration.

Purpose: (PURPOSE:)

Adenosinum Cyclophosphoricum – For temporary relief of insomnia, Alumen – For temporary relief of throat pain, Alumina – For temporary relief of fatigue, Antimonium Tartaricum – For temporary relief of dry mouth, Antipyrinum – For temporary relief of fatigue, Coenzyme A – For energy, Cuprum Metallicum – For temporary relief of dry mouth, Grindelia – For temporary relief of eye pain, Lachesis Mutus – For temporary relief of disordered sleep, Lycopodium Clavatum – For temporary relief of abnormal sleep, Manganum Phosphoricum – For temporary relief of sore throat, Phosphoricum Acidum – For temporary relief of debility, Phosphorus – For temporary relief of sleep disturbance, Rheum (Palmatum) – For temporary relief of dizziness, Sabadilla – For temporary relief of allergy, Sanguinarinum Nitricum – For temporary relief of nasal drip, Senega Officinalis – For temporary relief of cough, Silicea – For temporary relief of body ache, Zincum Metallicum – For temporary relief of weak memory

Warnings: (WARNINGS:)

As with any drug, ask a doctor before use if pregnant or nursing. Warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physicians promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

Keep this and all medications out of the reach of children.

In case of accidental overdose, contact a medical professional or poison control center immediately.

Questions: (QUESTIONS:)

Call weekdays 9am-5pm (918)791-1727

Distributed by:

Nucleic Products, LLC

PO Box 7148 Grove, OK 74344

Directions: (DIRECTIONS:)

Adults and Children 12 years of age and older: Take one full eyedropper twice a day to help alleviate symptoms of sleep disorders. Under 12 years of age: Consult a physician.

Other Information: (OTHER INFORMATION:)

Do not use if seal is broken or missing. This product does not contain sugar, starch, preservatives, artificial flavors or additives, and no wheat, gluten, soy, or milk derivatives.

Active Ingredients: (ACTIVE INGREDIENTS:)

Adenosinum Cyclophosphoricum 9X, 30C, 200C HPUS, Alumen 6X, 30C, 200C HPUS, Alumina 12X, 30C HPUS, Antimonium Tartaricum 9X, 30C, 200C HPUS, Antipyrinum 18X, 30C, 200C HPUS, Coenzyme A 12C, 30C, 200C HPUS, Cuprum Metallicum 12X, 30C HPUS, Grindelia 9X, 30C, 200C HPUS, Lachesis Mutus 12X, 30C, 200C HPUS, Lycopodium Clavatum 13X, 200C HPUS, Manganum Phosphoricum 15X, 30C HPUS, Phosphoricum Acidum 6X, 30C HPUS, Phosphorus 9X, 30C HPUS, Rheum (Palmatum) 12X, 30C, 200C HPUS, Sabadilla 9X, 30C, 200C HPUS, Sanguinarinum Nitricum 12X, 30C HPUS, Senega Officinalis 9X, 30C HPUS, Silicea 12X, 30C HPUS, Zincum Metallicum 12X, 30C, 200C HPUS.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

20% organic ethanol, purified water

Packaging Label Display: (PACKAGING LABEL DISPLAY:)

NDC: 75053-0008-1

Nu cleic

Apnetem

Temperare Regulation Series

Homeopathic Medicine

For Professional Use Only

4 fl oz. (118 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of accidental overdose, contact a medical professional or poison control center immediately.


Advanced Ingredient Data


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