Search by Drug Name or NDC

NDC 17089-0475-18 GUNA DIGESTION PLUS 3; 4; 6; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA DIGESTION PLUS 3; 4; 6; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

GUNA DIGESTION PLUS is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is AETHUSA CYNAPIUM; LYCOPODIUM CLAVATUM SPORE; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS.

Product Information

NDC	17089-0475
Product ID	17089-475_b8db0bfe-4e97-25dc-e053-2a95a90aa847
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	GUNA DIGESTION PLUS
Proprietary Name Suffix	n/a
Non-Proprietary Name	pork liver - lycopodium clavatum spore - strychnos nux vomica seed - sus scrofa pancreas - aethusa cynapium -
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	3; 4; 6; 4; 6
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	AETHUSA CYNAPIUM; LYCOPODIUM CLAVATUM SPORE; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS
Labeler Name	Guna spa
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0475-18 (17089047518)

Pricing Information	N/A
NDC Package Code	17089-475-18
Billing NDC	17089047518
Package	1 BOTTLE, DROPPER in 1 BOX (17089-475-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-02-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b8db0bfe-4e96-25dc-e053-2a95a90aa847 Details

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals

SPL UNCLASSIFIED SECTION

Inactive ingredient: Ethyl alcohol 30%.

QUESTIONS

Questions?: [email protected]

Tel. (484) 223-3500

DIRECTIONS

Take 15 minutes before meals.

Adults and children 12 years and older 20 drops in a little water, 2 times per day

Children between 12 and 6 years of age 10 drops in a little water, 2 times per day .

Children under 6 years consult a physician

WARNINGS

Keep out of reach of children

PREGNANCY

If pregnant or breast-feeding ask a health care professional before use

WARNINGS

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

If pregnant or breast-feeding ask a health care professional before use.

Do not use more than the recommended dose.

Keep out of reach of children.

In case of overdose, seek professional assistance or contact a Poison Control Center right away.

Contains ethyl alcohol 30%

USES

Temporary relief of indigestion symptoms such as:

drowsiness
nausea
constipation

ACTIVE INGREDIENTS/PURPOSE

Aethusa cynapium 3X Helps digestion, especially lactose

Hepar suis 6X Supports detoxification

Lycopodium clavatum 4X Helps digestion

Nux vomica 4X, 6X, 10X, 30X, 200X Helps digestion, relieves heartburn, sour stomach

Pancreas suis 6X Supports pancreatic function

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA DIGESTION PLUS

pork liver - lycopodium clavatum spore - strychnos nux vomica seed - sus scrofa pancreas - aethusa cynapium - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-475
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	6 [hp_X] in 30 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	4 [hp_X] in 30 mL
SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY)	SUS SCROFA PANCREAS	6 [hp_X] in 30 mL
AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C)	AETHUSA CYNAPIUM	3 [hp_X] in 30 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	4 [hp_X] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)	9 mL in 30 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-475-18	1 in 1 BOX	02/17/2021
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/17/2021

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-475)

Revised: 2/2021

Document Id: b8db0bfe-4e97-25dc-e053-2a95a90aa847

Set id: b8db0bfe-4e96-25dc-e053-2a95a90aa847

Version: 1

Effective Time: 20210217

Search by Drug Name or NDC

NDC 17089-0475-18 GUNA DIGESTION PLUS 3; 4; 6; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA DIGESTION PLUS 3; 4; 6; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Product Information

Package

Package Images

NDC 17089-0475-18 (17089047518)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b8db0bfe-4e96-25dc-e053-2a95a90aa847 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

QUESTIONS

DIRECTIONS

WARNINGS

PREGNANCY

WARNINGS

USES

ACTIVE INGREDIENTS/PURPOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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