| NDC | 57955-4127-1 |
| Set ID | 27d832c6-6462-4530-94ac-2bfc0cb2b72f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | King Bio Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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ACTIVE INGREDIENT
Drug Facts
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Active Ingredients: Adrenalinum 6X, Bryonia alba 6X, Lycopodium clavatum 6X, Natrum muriaticum 6X, Pulsatilla nigricans 6X, Histaminum hydrochloricum 12X, Avena sativa 12X, Glycine max 12X, Hordeum vulgare 12X, Secale cereale 12X, Triticum aestivum 12X, Zea mays 12X.
- INDICATIONS & USAGE
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WARNINGS
Warnings: Stop and ask a doctor if •symptoms do not impove in 5 days or new symptoms appear •you are a asthma sufferer with severe allergies.
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If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions: •do not use if printed bottle neck seal is broken or missing •adults and children 12 years and over take 15 drops under the tongue every 3-4 hours 3 times daily •children 2-12 years, take 3-5 drops under the tongue 3 times daily •sensitive persons and asthma sufferers take 1-3 drops and wait 3 hours then continue with regular dosage provided •if allergy or asthma symptoms develop discontinue use.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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PURPOSE
Drug Facts
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Active Ingredients Purpose
Adrenalinum 6X.......................................................decongestant
Bryonia alba 6X......................................relieves allergy symptoms
Lycopodium clavatum 6X.........................relieves allergy symptoms
Natrum muriaticum 6X............................relieves allergy symptoms
Pulsatilla nigricans 6X..............................relieves allergy symptoms
Histaminum hydrochloricum 12X................................antihistamine
Avena sativa 12X......................................................allergen (oat)
Glycine max 12X......................................................allergen (soy)
Hordeum vulgare 12X............................................allergen (barley)
Secale cereale 12X....................................................allergen (rye)
Triticum aestivum 12X...........................................allergen (wheat)
Zea mays 12X..........................................................allergen(corn)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GRAIN AND WHEAT
adrenalinum, bryonia alba, lycopodium clavatum, natrum muriaticum, pulsatilla nigricans, histaminum hydrochloricum, avena sativa, glycine max, hordeum vulgare, secale cereale, triticum aestivum, zea mays liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-4127 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE 6 [hp_X] in 30 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 30 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 6 [hp_X] in 30 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 30 mL PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS 6 [hp_X] in 30 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 12 [hp_X] in 30 mL AVENA SATIVA POLLEN (UNII: A7IKY24TR7) (AVENA SATIVA POLLEN - UNII:A7IKY24TR7) AVENA SATIVA POLLEN 12 [hp_X] in 30 mL SOYBEAN (UNII: L7HT8F1ZOD) (SOYBEAN - UNII:L7HT8F1ZOD) SOYBEAN 12 [hp_X] in 30 mL HORDEUM VULGARE POLLEN (UNII: 2LN3M29LNI) (HORDEUM VULGARE POLLEN - UNII:2LN3M29LNI) HORDEUM VULGARE POLLEN 12 [hp_X] in 30 mL SECALE CEREALE POLLEN (UNII: I6KAZ8AO1O) (SECALE CEREALE POLLEN - UNII:I6KAZ8AO1O) SECALE CEREALE POLLEN 12 [hp_X] in 30 mL TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (TRITICUM AESTIVUM POLLEN - UNII:F1KAH8374D) TRITICUM AESTIVUM POLLEN 12 [hp_X] in 30 mL ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 12 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-4127-1 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/13/2010 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-4127)
