Label: 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
- NDC Code(s): 17089-348-18
- Packager: Guna spa
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 21, 2018
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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
- WARNINGS
- PREGNANCY
- WARNINGS
- DIRECTIONS
- QUESTIONS
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
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/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17089-348 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 9 mL in 30 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/16/2008 Labeler - Guna spa (430538264) Establishment Name Address ID/FEI Business Operations Guna spa 338587646 manufacture(17089-348)