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NDC 17089-0470-18 GUNA BOWEL PLUS 6; 4; 6; 6; 2; 2; 2; 2; 6; 2; 2; 6; 6; 6; 6; 2; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA BOWEL PLUS 6; 4; 6; 6; 2; 2; 2; 2; 6; 2; 2; 6; 6; 6; 6; 2; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

GUNA BOWEL PLUS is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLLINSONIA; FRANGULA ALNUS BARK; LYCOPODIUM CLAVATUM SPORE; POTASSIUM CARBONATE; RHUBARB; SILYBUM MARIANUM SEED; SKATOLE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SUS SCR.

Product Information

NDC	17089-0470
Product ID	17089-470_b3aa6401-9af7-b0d5-e053-2995a90a10ef
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 BOWEL PLUS
Proprietary Name Suffix	n/a
Non-Proprietary Name	ACTIVATED CHARCOAL - ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - COLLINSONIA - FRANGULA ALNUS BARK - LYCOPODIUM CLAVATUM SPORE - POTASSIUM CARBONATE- RHUBARB - STRYCHNOS NUX VOMICA SEED - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBON
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	6; 4; 6; 6; 2; 2; 2; 2; 6; 2; 2; 6; 6; 6; 6; 2; 4
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLLINSONIA; FRANGULA ALNUS BARK; LYCOPODIUM CLAVATUM SPORE; POTASSIUM CARBONATE; RHUBARB; SILYBUM MARIANUM SEED; SKATOLE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SUS SCR
Labeler Name	Guna spa
Pharmaceutical Class	Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [E
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0470-18 (17089047018)

Pricing Information	N/A
NDC Package Code	17089-470-18
Billing NDC	17089047018
Package	1 BOTTLE, DROPPER in 1 BOX (17089-470-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-01-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b3aa4fd3-c87a-ccd2-e053-2995a90a46a9 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

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

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

Children under 6 years: consulta 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.
Keep out of reach of children. In case of accidental overdose, seek professional assitance ot or contact a Poison Control Center immediately
Contains Aloe: do not use orally for more than 30 days.
Contains ethyl alcohol 30%

USES

Temporary relief of gastrointestinal disorders, such as:

constipation
nausea
abdominal gas
impaired digestion

ACTIVE INGREDIENTS/PURPOSE

Aloe 4X Relieves constipation

Alumina 6X, 8X Relieves constipation

Bryonia 6X, 8X Relieves nausea, appetite disorders

Carbo vegetabilis 6X Helps digestion

Carduus marianus 2X Supports liver function

Chelidonium majus 2X Supports liver and gallbladder function

Collinsonia canadensis 2X Relieves hemorrhoids and constipation

Kali carbonicum 6X, 8X, 12X Relieves abdominal gas and nausea

Lycopodium clavatum 2X Supports liver function and drainage

Natrum carbonicum 6X, 8X, 12X Helps digestion

Nux vomica 6X, 8X Relieves abdominal gas and helps digestion

Pancreas suis 6X Relieves nausea, appetite disorders

Rhamnus frangula 2X Relieves nausea

Rheum 2X Relieves constipation

Skatolum 6X, 10X Helps digestion

Taraxacum officinale 2X Supports liver and gallbladder function

Thiaminum hydroc. 4X Relieves abdominal gas and helps digestion

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA BOWEL PLUS

activated charcoal - aloe - aluminum oxide - bryonia alba root - chelidonium majus - collinsonia - frangula alnus bark - lycopodium clavatum spore - potassium carbonate- rhubarb - strychnos nux vomica seed - silybum marianum seed - skatole - sodium carbonate - sus scrofa pancreas - taraxacum officinale - thiamine - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-470
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	4 [hp_X] in 30 mL
ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933)	ALUMINUM OXIDE	6 [hp_X] in 30 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X] in 30 mL
SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE)	SILYBUM MARIANUM SEED	2 [hp_X] in 30 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	2 [hp_X] in 30 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	6 [hp_X] in 30 mL
COLLINSONIA (UNII: J9BTD5377V) (COLLINSONIA - UNII:J9BTD5377V)	COLLINSONIA	2 [hp_X] in 30 mL
SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY)	SUS SCROFA PANCREAS	6 [hp_X] in 30 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	6 [hp_X] in 30 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D)	SODIUM CARBONATE	6 [hp_X] in 30 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	2 [hp_X] in 30 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_X] in 30 mL
FRANGULA ALNUS BARK (UNII: S2D77IH61R) (FRANGULA ALNUS BARK - UNII:S2D77IH61R)	FRANGULA ALNUS BARK	2 [hp_X] in 30 mL
RHUBARB (UNII: G280W4MW6E) (RHUBARB - UNII:G280W4MW6E)	RHUBARB	2 [hp_X] in 30 mL
SKATOLE (UNII: 9W945B5H7R) (SKATOLE - UNII:9W945B5H7R)	SKATOLE	6 [hp_X] in 30 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	2 [hp_X] in 30 mL
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	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:17089-470-18	1 in 1 BOX	01/17/2021
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		01/17/2021

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-470)

Revised: 1/2021

Document Id: b3aa6401-9af7-b0d5-e053-2995a90a10ef

Set id: b3aa4fd3-c87a-ccd2-e053-2995a90a46a9

Version: 1

Effective Time: 20210117

Search by Drug Name or NDC

GUNA BOWEL PLUS 6; 4; 6; 6; 2; 2; 2; 2; 6; 2; 2; 6; 6; 6; 6; 2; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Product Information

Package

Package Images

NDC 17089-0470-18 (17089047018)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b3aa4fd3-c87a-ccd2-e053-2995a90a46a9 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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