GUNA-SPASM- atropine sulfate - berberis vulgaris root bark - chelidonium majus - cobalt - cultivated mushroom - gelsemium sempervirens root - interleukin-10 - magnesium - melatonin - metenkefalin - sus scrofa sympathetic nerve - sus scrofa vagus nerve - watermelon - anti-interleukin-1.alpha. immunoglobulin g rabbit - 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.

----------

GUNA-SPASM

ACTIVE INGREDIENTS/PURPOSE

AGARICUS CAMPESTRIS         4X    ANTISPASTIC
ANTI INTERLEUKIN 1 ALPHA     4C    ANTI-INFLAMMATORY
ATROPINUM SULFURICUM         6X    PAIN RELIEF
BERBERIS VULGARIS         3X    DETOXIFICATION
BETA-ENDORPHIN             4C    PAIN RELIEF
CHELIDONIUM MAJUS         4X    DETOXIFICATION
COBALTUM METALLICUM         4X    ANTISPASTIC
COLOCYNTHIS             4X    BACK SORE
GELSEMIUM             6X    ANALGESIC
INTERLEUKIN 10             4C    ANTI-INFLAMMATORY
MAGNESIUM METALLICUM         4X    ANTISPASTIC
MELATONIN             4C    ANTISPASTIC
SYMPATHETIC NERVE        200X    PAIN RELIEF
VAGAL NERVE            6X    PAIN RELIEF

USES

Temporary relief of:

Muscle spasms
Colic gas pain

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%

PREGNANCY

If pregnant or breast-feeding ask a doctor before use

WARNINGS

Keep this and all medicines out of reach of children

DIRECTIONS

Adults and children 12 years and older 20 drops in a little, 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 5 drops in a glass of water, 2 times per day

QUESTIONS

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

Take 15 minutes before meals

Inactive Ingredient: Ethyl alcohol 30%.

PRINCIPAL DISPLAY PANEL

5USSPA-Rev05-27-04-18

GUNA-SPASM
atropine sulfate - berberis vulgaris root bark - chelidonium majus - cobalt - cultivated mushroom - gelsemium sempervirens root - interleukin-10 - magnesium - melatonin - metenkefalin - sus scrofa sympathetic nerve - sus scrofa vagus nerve - watermelon - anti-interleukin-1.alpha. immunoglobulin g rabbit - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-348
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CULTIVATED MUSHROOM (UNII: 54C8E6W6JY) (CULTIVATED MUSHROOM - UNII:54C8E6W6JY)	CULTIVATED MUSHROOM	4 [hp_X] in 30 mL
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT (UNII: ML4QRZ1HCL) (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - UNII:ML4QRZ1HCL)	ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT	4 [hp_C] in 30 mL
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	ATROPINE SULFATE	6 [hp_X] in 30 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	3 [hp_X] in 30 mL
METENKEFALIN (UNII: 9JEZ9OD3AS) (METENKEFALIN - UNII:9JEZ9OD3AS)	METENKEFALIN	4 [hp_C] in 30 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	4 [hp_X] in 30 mL
COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362)	COBALT	4 [hp_X] in 30 mL
WATERMELON (UNII: 231473QB6R) (WATERMELON - UNII:231473QB6R)	WATERMELON	4 [hp_X] in 30 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X] in 30 mL
INTERLEUKIN-10 (UNII: 9SC4O216V9) (INTERLEUKIN-10 - UNII:9SC4O216V9)	INTERLEUKIN-10	4 [hp_C] in 30 mL
MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A)	MAGNESIUM	4 [hp_X] in 30 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	4 [hp_C] in 30 mL
SUS SCROFA SYMPATHETIC NERVE (UNII: H6L0IFR3FE) (SUS SCROFA SYMPATHETIC NERVE - UNII:H6L0IFR3FE)	SUS SCROFA SYMPATHETIC NERVE	200 [hp_X] in 30 mL
SUS SCROFA VAGUS NERVE (UNII: 5AZZ2GHR69) (SUS SCROFA VAGUS NERVE - UNII:5AZZ2GHR69)	SUS SCROFA VAGUS NERVE	6 [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:17089-348-18	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		04/16/2008

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-348)