Search by Drug Name or NDC

NDC 17089-0501-18 GUNA FEMALE SUPPORT 6; 6; 10; 8; 10; 30; 30; 6; 30; 30 [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 FEMALE SUPPORT 6; 6; 10; 8; 10; 30; 30; 6; 30; 30 [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 FEMALE SUPPORT is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is ADENOSINE CYCLIC PHOSPHATE; LILIUM LANCIFOLIUM WHOLE FLOWERING; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA PIT.

Product Information

NDC	17089-0501
Product ID	17089-501_bb2217fc-c752-20b1-e053-2995a90a2562
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 FEMALE SUPPORT
Proprietary Name Suffix	n/a
Non-Proprietary Name	lilium lancifolium whole flowering - sus scrofa ovary - sus scrofa pituitary gland - sepia officinalis juice - adenosine cyclic phosphate - pulsatilla vulgaris - sus scrofa hypothalamus - sus scrofa adrenal gland - sus scrofa pancreas - magnesium phosphat
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	6; 6; 10; 8; 10; 30; 30; 6; 30; 30
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
Substance Name	ADENOSINE CYCLIC PHOSPHATE; LILIUM LANCIFOLIUM WHOLE FLOWERING; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA PIT
Labeler Name	Guna spa
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0501-18 (17089050118)

Pricing Information	N/A
NDC Package Code	17089-501-18
Billing NDC	17089050118
Package	1 BOTTLE, DROPPER in 1 BOX (17089-501-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-02-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bb22182f-a503-433f-e053-2995a90a2f47 Details

DIRECTIONS

Take 15 minutes before meals.

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

Children under 12 years: consult a physician

ACTIVE INGREDIENTS/PURPOSE

Adenosinum cylclophosphoricum 6X Relieves mood swings

Glandula suprarenalis suis 30X Relieves menstrual pain

Hypophysis suis 30X Supports ovary function, fertility

Hypothalamus suis 30X Supports endocrine function

Lilium tigrinum 6X Relieves menstrual pain

Magnesia phosphorica 10X Relieves menstrual pain

Oophorinum 6X Supports ovary function, fertility

Pancreas suis 30X Supports menstrual regularity

Pulsatilla 8X Supports menstrual regularity

Sepia officinalis 10X Supports menstrual regularity

USES

Temporarily relieves symptoms of female hormonal imbalance, such as:

mood swings
menstrual irregularities
menstrual cramps.

SPL UNCLASSIFIED SECTION

Inactive ingredient: Ethyl alcohol 30%.

QUESTIONS

Questions?

[email protected]

Tel. (484) 223-3500

WARNINGS

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals.

PREGNANCY

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

WARNINGS

Stop use and ask doctor if symptoms worsen or 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 assistance or contact a poison control center immediately
Contains ethyl alcohol 30%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA FEMALE SUPPORT

lilium lancifolium whole flowering - sus scrofa ovary - sus scrofa pituitary gland - sepia officinalis juice - adenosine cyclic phosphate - pulsatilla vulgaris - sus scrofa hypothalamus - sus scrofa adrenal gland - sus scrofa pancreas - magnesium phosphate dibasic trihydrate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-501
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI)	LILIUM LANCIFOLIUM WHOLE FLOWERING	6 [hp_X] in 30 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	6 [hp_X] in 30 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	10 [hp_X] in 30 mL
ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) (ADENOSINE CYCLIC PHOSPHATE - UNII:E0399OZS9N)	ADENOSINE CYCLIC PHOSPHATE	6 [hp_X] in 30 mL
SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT)	SUS SCROFA PITUITARY GLAND	30 [hp_X] in 30 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	30 [hp_X] in 30 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	30 [hp_X] in 30 mL
SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY)	SUS SCROFA PANCREAS	30 [hp_X] in 30 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	10 [hp_X] in 30 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	8 [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:17089-501-18	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(17089-501)

Revised: 2/2021

Document Id: bb2217fc-c752-20b1-e053-2995a90a2562

Set id: bb22182f-a503-433f-e053-2995a90a2f47

Version: 1

Effective Time: 20210212

Search by Drug Name or NDC

NDC 17089-0501-18 GUNA FEMALE SUPPORT 6; 6; 10; 8; 10; 30; 30; 6; 30; 30 [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 FEMALE SUPPORT 6; 6; 10; 8; 10; 30; 30; 6; 30; 30 [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 17089-0501-18 (17089050118)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL bb22182f-a503-433f-e053-2995a90a2f47 Details

DIRECTIONS

ACTIVE INGREDIENTS/PURPOSE

USES

SPL UNCLASSIFIED SECTION

QUESTIONS

WARNINGS

SPL UNCLASSIFIED SECTION

PREGNANCY

WARNINGS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

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