Guna-reflux

Guna-reflux
SPL v3
SPL
SPL Set ID 444c1f4c-dd0c-4525-bb65-c0c211c9487f
Route
ORAL
Published
Effective Date 2018-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aethusa Cynapium (9 mL) Apomorphine (4 [hp_X]) Bryonia Alba Root (6 [hp_X]) Activated Charcoal (30 [hp_X]) Sus Scrofa Stomach (12 [hp_X]) Colchicum Autumnale Bulb (10 [hp_X]) Watermelon (5 [hp_X]) Sus Scrofa Esophagus Strychnos Ignatii Seed Ipecac Lycopodium Clavatum Spore Strychnos Nux-vomica Seed
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-05-12

Description

AETHUSA CYNAPIUM 4X DIGESTIVE APOMORPHINE HYDROCHLORIDE 6X PAIN RELIEF BRYONIA ALBA 4X, 10X, 30X, 200X ANTITUSSIVE CARBO VEGETALIS 12X ANTITUSSIVE CARDIA VENTRICULI 10X GAS COLCHICUM AUTUMNALE 6X ANTI-INFLAMMATORY COLOCYNTHIS 5X, 10X, 30X, 200X NERVOUS IRRITATION RELIEF ESOPHAGUS 10X DIGESTIVE IGNATIA AMARA 6X ANTISTRESS IPECACUANHA 4X ANTITUSSIVE LYCOPODIUM CLAVATUM 5X, 10X, 30X, 200X DETOXIFICATION NUX VOMICA 4X, 10X, 30X, 200X ACID REFLUX

Purpose

AETHUSA CYNAPIUM 4X DIGESTIVE APOMORPHINE HYDROCHLORIDE 6X PAIN RELIEF BRYONIA ALBA 4X, 10X, 30X, 200X ANTITUSSIVE CARBO VEGETALIS 12X ANTITUSSIVE CARDIA VENTRICULI 10X GAS COLCHICUM AUTUMNALE 6X ANTI-INFLAMMATORY COLOCYNTHIS 5X, 10X, 30X, 200X NERVOUS IRRITATION RELIEF ESOPHAGUS 10X DIGESTIVE IGNATIA AMARA 6X ANTISTRESS IPECACUANHA 4X ANTITUSSIVE LYCOPODIUM CLAVATUM 5X, 10X, 30X, 200X DETOXIFICATION NUX VOMICA 4X, 10X, 30X, 200X ACID REFLUX


Medication Information

Indications and Usage

Take 15 minutes before meals

Purpose

AETHUSA CYNAPIUM 4X DIGESTIVE APOMORPHINE HYDROCHLORIDE 6X PAIN RELIEF BRYONIA ALBA 4X, 10X, 30X, 200X ANTITUSSIVE CARBO VEGETALIS 12X ANTITUSSIVE CARDIA VENTRICULI 10X GAS COLCHICUM AUTUMNALE 6X ANTI-INFLAMMATORY COLOCYNTHIS 5X, 10X, 30X, 200X NERVOUS IRRITATION RELIEF ESOPHAGUS 10X DIGESTIVE IGNATIA AMARA 6X ANTISTRESS IPECACUANHA 4X ANTITUSSIVE LYCOPODIUM CLAVATUM 5X, 10X, 30X, 200X DETOXIFICATION NUX VOMICA 4X, 10X, 30X, 200X ACID REFLUX

Description

AETHUSA CYNAPIUM 4X DIGESTIVE APOMORPHINE HYDROCHLORIDE 6X PAIN RELIEF BRYONIA ALBA 4X, 10X, 30X, 200X ANTITUSSIVE CARBO VEGETALIS 12X ANTITUSSIVE CARDIA VENTRICULI 10X GAS COLCHICUM AUTUMNALE 6X ANTI-INFLAMMATORY COLOCYNTHIS 5X, 10X, 30X, 200X NERVOUS IRRITATION RELIEF ESOPHAGUS 10X DIGESTIVE IGNATIA AMARA 6X ANTISTRESS IPECACUANHA 4X ANTITUSSIVE LYCOPODIUM CLAVATUM 5X, 10X, 30X, 200X DETOXIFICATION NUX VOMICA 4X, 10X, 30X, 200X ACID REFLUX

Uses





Temporary relief of GERD symptoms such as:

  • Occasional heartburn
  • Acir taste in the mouth
  • Occasional cough at night
Section 51727-6

Inactive ingredient: Ethyl alcohol 30%.

Warnings

Stop use and ask doctor if symptoms persist more than 5 days.

If pregnant or breast-feeding 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.

Contains ethyl alcohol 30%

Pregnancy

If pregnant or breast-feeding ask a doctor before use

Questions

Questions?: [email protected]

Tel. (484) 223-3500



Directions



Adults and children 12 years and older 10 drops in a little water 3 times per day



Children between 12 years and 6 years of age 7 drops in a little water 3 times per day



Children under 6 years 5 drops in a glass of water 3 times per day

Principal Display Panel

Active Ingredients/purpose

AETHUSA CYNAPIUM 4X DIGESTIVE



APOMORPHINE HYDROCHLORIDE 6X PAIN RELIEF



BRYONIA ALBA 4X, 10X, 30X, 200X ANTITUSSIVE



CARBO VEGETALIS 12X ANTITUSSIVE



CARDIA VENTRICULI 10X GAS



COLCHICUM AUTUMNALE 6X ANTI-INFLAMMATORY



COLOCYNTHIS 5X, 10X, 30X, 200X NERVOUS IRRITATION RELIEF



ESOPHAGUS 10X DIGESTIVE



IGNATIA AMARA 6X ANTISTRESS



IPECACUANHA 4X ANTITUSSIVE



LYCOPODIUM CLAVATUM 5X, 10X, 30X, 200X DETOXIFICATION



NUX VOMICA 4X, 10X, 30X, 200X ACID REFLUX






Structured Label Content

Uses (USES)





Temporary relief of GERD symptoms such as:

  • Occasional heartburn
  • Acir taste in the mouth
  • Occasional cough at night
Indications and Usage (34067-9)

Take 15 minutes before meals

Section 51727-6 (51727-6)

Inactive ingredient: Ethyl alcohol 30%.

Warnings (WARNINGS)

Stop use and ask doctor if symptoms persist more than 5 days.

If pregnant or breast-feeding 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.

Contains ethyl alcohol 30%

Pregnancy (PREGNANCY)

If pregnant or breast-feeding ask a doctor before use

Questions (QUESTIONS)

Questions?: [email protected]

Tel. (484) 223-3500



Directions (DIRECTIONS)



Adults and children 12 years and older 10 drops in a little water 3 times per day



Children between 12 years and 6 years of age 7 drops in a little water 3 times per day



Children under 6 years 5 drops in a glass of water 3 times per day

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Active Ingredients/purpose (ACTIVE INGREDIENTS/PURPOSE)

AETHUSA CYNAPIUM 4X DIGESTIVE



APOMORPHINE HYDROCHLORIDE 6X PAIN RELIEF



BRYONIA ALBA 4X, 10X, 30X, 200X ANTITUSSIVE



CARBO VEGETALIS 12X ANTITUSSIVE



CARDIA VENTRICULI 10X GAS



COLCHICUM AUTUMNALE 6X ANTI-INFLAMMATORY



COLOCYNTHIS 5X, 10X, 30X, 200X NERVOUS IRRITATION RELIEF



ESOPHAGUS 10X DIGESTIVE



IGNATIA AMARA 6X ANTISTRESS



IPECACUANHA 4X ANTITUSSIVE



LYCOPODIUM CLAVATUM 5X, 10X, 30X, 200X DETOXIFICATION



NUX VOMICA 4X, 10X, 30X, 200X ACID REFLUX






Advanced Ingredient Data


Raw Label Data

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