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NDC 17089-0477-21 GUNA STOMACH PLUS 6; 6; 4; 8; 6; 6; 4; 4; 6 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g Details

GUNA STOMACH PLUS 6; 6; 4; 8; 6; 6; 4; 4; 6 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g

GUNA STOMACH PLUS is a ORAL PELLET in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; COPPER; IPECAC; ORIGANUM MAJORANA; SILVER NITRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE ROOT.

Product Information

NDC	17089-0477
Product ID	17089-477_c718c487-6d75-19aa-e053-2995a90aa549
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 STOMACH PLUS
Proprietary Name Suffix	n/a
Non-Proprietary Name	Antimonium crudum - Argentum nitricum - Arsenicum album - Ipecacuanha - Nux vomica - Origanum majorana - Cuprum metallicum - Taraxacum officinale - Natrum phosphoricum -
Product Type	HUMAN OTC DRUG
Dosage Form	PELLET
Route	ORAL
Active Ingredient Strength	6; 6; 4; 8; 6; 6; 4; 4; 6
Active Ingredient Units	[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g
Substance Name	ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; COPPER; IPECAC; ORIGANUM MAJORANA; SILVER NITRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE ROOT
Labeler Name	Guna spa
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large I
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0477-21 (17089047721)

Pricing Information	N/A
NDC Package Code	17089-477-21
Billing NDC	17089047721
Package	1 TUBE in 1 BOX (17089-477-21) / 4 g in 1 TUBE
Marketing Start Date	2021-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba495fce-b7ad-af83-e053-2a95a90a388a Details

ACTIVE INGREDIENTS/PURPOSE

Antimonium crudum 6X Relieves heartburn

Argentum nitricum 6X Relieves heartburn

Arsenicum album 6X Relieves indigestion and nausea

Ipecacuanha 8X, 30X, 200X Relieves nausea and vomiting

Nux vomica 4X Relieves heartburn, stomach pain

Origanum majorana 6X Loss of appetite, hiccough

Cuprum metallicum 4X Relieves stomach cramps

Taraxacum officinale 6X Relieves heartburn, sour stomach

Natrum phosphoricum 4X Relieves heartburn, sour stomach

SPL UNCLASSIFIED SECTION

Stop use and ask doctor if symptoms persist more than 5 days or worsen.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children.

USES

Relieves symptoms of acid reflux and gastritis such as:

heartburn
sour stomach
nausea after eating

SPL UNCLASSIFIED SECTION

Relieves symptoms of acid reflux and gastritis such as:

heartburn
sour stomach
nausea after eating

QUESTIONS

Questions?

[email protected]

(484) 223-3500

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 or worsen.
If pregnant or breast-feeding ask a health care professional before use
keep out of reach of children

DIRECTIONS

Turn tube upside down and rotate cap to release pellets into cap. ● Unscrew cap and, without touching the pellets, place them under the tongue. ● Allow to dissolve. ● Take 15 minutes before meals.

SPL UNCLASSIFIED SECTION

Adults and children 12 years and older 5 pellets 3 times per day
Children between 12 and 6 years of age 3 pellets 3 times per day
Children under 6 years 1 pellet 3 times per day to be disoolved into a little water

SPL UNCLASSIFIED SECTION

Inactive ingredient: Sucrose.

SPL UNCLASSIFIED SECTION

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA STOMACH PLUS

antimonium crudum - argentum nitricum - arsenicum album - ipecacuanha - nux vomica - origanum majorana - cuprum metallicum - taraxacum officinale - natrum phosphoricum - pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-477
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	4 [hp_X] in 4 g
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	6 [hp_X] in 4 g
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	4 [hp_X] in 4 g
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	8 [hp_X] in 4 g
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	6 [hp_X] in 4 g
ORIGANUM MAJORANA (UNII: R40XM3HU5X) (ORIGANUM MAJORANA - UNII:R40XM3HU5X)	ORIGANUM MAJORANA	6 [hp_X] in 4 g
TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU) (TARAXACUM OFFICINALE ROOT - UNII:9DE5YCO0RU)	TARAXACUM OFFICINALE ROOT	6 [hp_X] in 4 g
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	4 [hp_X] in 4 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	6 [hp_X] in 4 g

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)	4 g in 4 g

Product Characteristics
Color	white (white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-477-20	2 in 1 BOX	02/17/2021
1		4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:17089-477-21	1 in 1 BOX	12/15/2021
2		4 g in 1 TUBE; 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(17089-477)

Revised: 12/2021

Document Id: c718c487-6d75-19aa-e053-2995a90aa549

Set id: ba495fce-b7ad-af83-e053-2a95a90a388a

Version: 2

Effective Time: 20211215

Search by Drug Name or NDC

NDC 17089-0477-21 GUNA STOMACH PLUS 6; 6; 4; 8; 6; 6; 4; 4; 6 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g Details

GUNA STOMACH PLUS 6; 6; 4; 8; 6; 6; 4; 4; 6 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g

Product Information

Package

Package Images

NDC 17089-0477-21 (17089047721)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ba495fce-b7ad-af83-e053-2a95a90a388a Details

ACTIVE INGREDIENTS/PURPOSE

SPL UNCLASSIFIED SECTION

USES

SPL UNCLASSIFIED SECTION

QUESTIONS

WARNINGS

PREGNANCY

WARNINGS

DIRECTIONS

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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