SPL v1
SPL
SPL Set ID 08ea860f-0183-8ce8-e063-6394a90a582b
Route
ORAL
Published
Effective Date 2023-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cypripedium Parviflorum Var. Pubescens Root (4 [hp_X]) Hydrochloric Acid (12 [hp_X]) Arabica Coffee Bean (200 [hp_C]) Strychnos Ignatii Seed (30 [hp_C]) Zinc (6 [hp_X]) Hyoscyamus Niger Sulfur Potassium Phosphate, Unspecified Form
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-10-30

Description

Temporarily relieves symptoms associated with sleeplessness such as the inability to fall asleep or return to sleep after waking, restlessness, nervousness, worry, and excitability, to restore a more natural sleep pattern.


Medication Information

Description

Temporarily relieves symptoms associated with sleeplessness such as the inability to fall asleep or return to sleep after waking, restlessness, nervousness, worry, and excitability, to restore a more natural sleep pattern.

Label

Section 42229-5

Micro balance Health Products

Doctor Formulated

Homeopathic Sleep Support

Ahh Sleep

Restful Nights, Brighter Days

Melationin-free. No next -day grogginess. Non-habit forming.

Alcohol USP20%

1 fl oz(30ml)

Section 50565-1

Keep out of reach of children

Section 53414-9

If you are pregnant, breastfeeding, or for use in children under 12, consult with a helthcare prefessional. In case of accidental overdose, get medical help or contact a Posion Control Center right away. If symptoms worsen or persist for more than 2 weeks, consult a physician.

Section 55105-1

Temporarily relieves symptoms associated with sleeplessness such as the inability to fall asleep or return to sleep after waking, restlessness, nervousness, worry, and excitability, to restore a more natural sleep pattern.

Warnings

If you are pregnant, breastfeeding, or for use in children under 12, consult with a helthcare prefessional. In case of accidental overdose, get medical help or contact a Posion Control Center right away. If symptoms worsen or persist for more than 2 weeks, consult a physician.

Directions

Adults and children over 12: Apply 2-4 sprays under the tongue before bedtime. For best results, hold spray under the tongue 15 seconds before swallow. Addtional sprays may be taken during the night as needed. Do not take within 15 minutes of consuming food or brushing teeth.

Do Not Use

Do not use if tamper evident seal is broken or missing. Store in a cool place after opening.

Indication

Temporarily relieves symptoms associated with sleeplessness such as the inability to fall asleep or return to sleep after waking, restlessness, nervousness, worry, and excitability, to restore a more natural sleep pattern.

Active Ingredients

Coffea cruda (coffee) 200 C;

Cypripedium ( Lady's Slipper Orchid) 4x,

Hyoscyamus Niger (Henbane) 30C;

Ignatia Amara 12X;

Kalium Phosphoricum (Potassium Phosphate) 12X,

Muriaticum Acidum (Muriatic Acid) 12X;

Sulphur 6X;

Zincum Metallicum (Zinc) 12X

Inactive Ingredients

Alcohol USP 20%;

Water


Structured Label Content

Label (label)

Section 42229-5 (42229-5)

Micro balance Health Products

Doctor Formulated

Homeopathic Sleep Support

Ahh Sleep

Restful Nights, Brighter Days

Melationin-free. No next -day grogginess. Non-habit forming.

Alcohol USP20%

1 fl oz(30ml)

Section 50565-1 (50565-1)

Keep out of reach of children

Section 53414-9 (53414-9)

If you are pregnant, breastfeeding, or for use in children under 12, consult with a helthcare prefessional. In case of accidental overdose, get medical help or contact a Posion Control Center right away. If symptoms worsen or persist for more than 2 weeks, consult a physician.

Section 55105-1 (55105-1)

Temporarily relieves symptoms associated with sleeplessness such as the inability to fall asleep or return to sleep after waking, restlessness, nervousness, worry, and excitability, to restore a more natural sleep pattern.

Warnings

If you are pregnant, breastfeeding, or for use in children under 12, consult with a helthcare prefessional. In case of accidental overdose, get medical help or contact a Posion Control Center right away. If symptoms worsen or persist for more than 2 weeks, consult a physician.

Directions

Adults and children over 12: Apply 2-4 sprays under the tongue before bedtime. For best results, hold spray under the tongue 15 seconds before swallow. Addtional sprays may be taken during the night as needed. Do not take within 15 minutes of consuming food or brushing teeth.

Do Not Use (Do not use)

Do not use if tamper evident seal is broken or missing. Store in a cool place after opening.

Indication

Temporarily relieves symptoms associated with sleeplessness such as the inability to fall asleep or return to sleep after waking, restlessness, nervousness, worry, and excitability, to restore a more natural sleep pattern.

Active Ingredients (Active ingredients)

Coffea cruda (coffee) 200 C;

Cypripedium ( Lady's Slipper Orchid) 4x,

Hyoscyamus Niger (Henbane) 30C;

Ignatia Amara 12X;

Kalium Phosphoricum (Potassium Phosphate) 12X,

Muriaticum Acidum (Muriatic Acid) 12X;

Sulphur 6X;

Zincum Metallicum (Zinc) 12X

Inactive Ingredients

Alcohol USP 20%;

Water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)