Lower Gi Restoration™

Lower Gi Restoration™
SPL v2
SPL
SPL Set ID 985b51b6-32da-433e-9cf7-60f685ead454
Route
ORAL
Published
Effective Date 2016-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aethusa Cynapium (10 [hp_X]) Garlic Baptisia Tinctoria Root Capsicum Activated Charcoal Matricaria Recutita Cinchona Officinalis Bark Collinsonia Canadensis Root Citrullus Colocynthis Fruit Pulp Marsdenia Condurango Bark Gamboge Gratiola Officinalis Cow Milk Lactic Acid, Dl- Carbonate Ion Strychnos Nux-vomica Seed Podophyllum Sepia Officinalis Juice Silicon Dioxide
Inactive Ingredients
Water Anhydrous Citric Acid Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-04-08

Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients: Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltaum, Sepia, Silicea​. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.


Medication Information

Warnings and Precautions

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.
Indications and Usage

Uses for temporary relief of symptoms of lower gastrointestinal distress: gas bloating, constipation, hemorrhoids, abdominal cramping, diarrhea, flatulence, gastrointestinal inflammation.

Dosage and Administration

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day.
  • Children 2-12 years: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.
Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients: Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltaum, Sepia, Silicea​. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 50565-1
  • Keep out of reach of children.
Section 51727-6

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Section 51945-4

Section 55105-1

Uses ​for temporary relief of symptoms of lower gastrointestinal distress:

  • gas bloating
  • constipation
  • hemorrhoids
  • abdominal cramping
  • diarrhea
  • flatulence
  • gastrointestinal inflammation
Section 55106-9

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltaum, Sepia, Silicea​. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 60561-8

Tamper resistant for your protection . Use only if safety seal is intact. This product has not been clinically tested.


Structured Label Content

Indications and Usage (34067-9)

Uses for temporary relief of symptoms of lower gastrointestinal distress: gas bloating, constipation, hemorrhoids, abdominal cramping, diarrhea, flatulence, gastrointestinal inflammation.

Dosage and Administration (34068-7)

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day.
  • Children 2-12 years: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.
Warnings and Precautions (34071-1)

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.
Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses ​for temporary relief of symptoms of lower gastrointestinal distress:

  • gas bloating
  • constipation
  • hemorrhoids
  • abdominal cramping
  • diarrhea
  • flatulence
  • gastrointestinal inflammation
Section 55106-9 (55106-9)

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltaum, Sepia, Silicea​. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 60561-8 (60561-8)

Tamper resistant for your protection . Use only if safety seal is intact. This product has not been clinically tested.


Advanced Ingredient Data


Raw Label Data

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