GUNA-PMS- arsenic trioxide - estradiol - goldenseal - lachesis muta venom - magnesium phosphate - matricaria recutita - melatonin - progesterone - strychnos nux-vomica seed - sulfur - sus scrofa ovary - sus scrofa pituitary gland - solution/ drops
Guna spa

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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GUNA-PMS

ACTIVE INGREDIENTS/PURPOSE

ARSENICUM ALBUM 6C MOOD SUPPORT

BETA-ESTRADIOL 6X VAGINAL DRYNESS

CHAMOMILLA 6C CALMING

HYDRASTIS CANADENSIS 6C ANALGESIC

HYPOPHYSIS 8X HORMONAL REGULATION

LACHESIS MUTUS 4C ANXIETY

MAGNESIA PHOSPHORICA 6C METABOLIC SUPPORT

MELATONIN 4C HORMONAL BALANCE

NUX VOMICA 6C MOOD SUPPORT

OOPHORINUM 8X IRREGULAR MENSES

PROGESTERONE 6X IRREGULAR MENSES

SULFUR 6C DETOXIFICATION

USES

Temporary relief of symptoms due to Premenstrual Syndrome such as:

Moodiness
Cramping
Backache

PREGNANCY

If pregnant or breast-feeding ask a doctor before use

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%

DIRECTIONS

Adults: 20 drops in a little water, 2 times per day.

QUESTIONS

Questions?: info@gunainc.com, tel. (484) 223-3500

KEEP OUT OF REACH OF CHILDREN

Take 15 minutes before meals

Inactive ingredient: Ethyal alcohol 30%.

PRINCIPAL DISPLAY PANEL

5USPMS-Rev04-03-07-18

GUNA-PMS
arsenic trioxide - estradiol - goldenseal - lachesis muta venom - magnesium phosphate - matricaria recutita - melatonin - progesterone - strychnos nux-vomica seed - sulfur - sus scrofa ovary - sus scrofa pituitary gland - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-290
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	6 [hp_C] in 30 mL
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	6 [hp_X] in 30 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_C] in 30 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	4 [hp_C] in 30 mL
MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE (UNII: 453COF7817) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE	6 [hp_C] in 30 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_C] in 30 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	4 [hp_C] in 30 mL
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)	PROGESTERONE	6 [hp_X] in 30 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_C] in 30 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_C] in 30 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	8 [hp_X] in 30 mL
SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T)	SUS SCROFA PITUITARY GLAND	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:17089-290-18	1 in 1 BOX	12/21/2018
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		05/23/2006

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-290)