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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ASPERGILLUS NIGER VAR. NIGER: 11 Adverse Event Reports & Safety Profile

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11
Total FAERS Reports
0
Deaths Reported
0
Hospitalizations
11
As Primary/Secondary Suspect
Symbiopathic
Manufacturer

Drug Class: Allergens [CS] · Route: ORAL · Manufacturer: Symbiopathic · HUMAN OTC DRUG · FDA Label: Available

First Report: 20140801 · Latest Report: 20160830

What Are the Most Common ASPERGILLUS NIGER VAR. NIGER Side Effects?

#1 Most Reported
Throat irritation
6 reports (54.5%)
#2 Most Reported
Cough
6 reports (54.5%)
#3 Most Reported
Swelling
4 reports (36.4%)

All ASPERGILLUS NIGER VAR. NIGER Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Cough 6 54.6% 0 0
Throat irritation 6 54.6% 0 0

Who Reports ASPERGILLUS NIGER VAR. NIGER Side Effects? Age & Gender Data

Gender: 90.9% female, 9.1% male. Average age: 51.8 years. Most reports from: US. View detailed demographics →

Is ASPERGILLUS NIGER VAR. NIGER Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 4 0 0
2016 4 0 0

View full timeline →

Other Drugs in Same Class: Allergens [CS]

GOLD (4,133) PEANUT (2,334) GLYCERIN (1,146) PHLEUM PRATENSE POLLEN (891) BENZOCAINE (548) TOBACCO LEAF (324) CRANBERRY (319) AMBROSIA ARTEMISIIFOLIA POLLEN (308) View all → Class side effects → Compare in class →

Official FDA Label for ASPERGILLUS NIGER VAR. NIGER

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to ear, nose and throat infections including sinus/nasal congestion, cough, and mucous congestion in the middle ear and sneezing.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Dosage & Administration

DIRECTIONS:

  • Adults and Children over 12: For sinus symptoms apply 3-9 sprays under tongue 2-3 times daily, or as needed.
  • Use 9 sprays under tongue, 3 times daily when symptoms increase or additional immune support is needed.
  • Hold spray under tongue for 15 seconds before swallowing. Consult a physician for use in children under 12 years of age. Do not take within 15 minutes of consuming food or brushing teeth.

Warnings

WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by a physician.

Tamper

Evident: Sealed for your protection. Do not use if seal is broken or missing.

Active Ingredient

ACTIVE INGREDIENTS: Aspergillus Niger 16X, Babesia Microti 16X, Borrelia Burgdorferi 16X, Candida Albicans 16X, Candida Parapsilosis 16X, Chlamydia Trachomatis 16X, Colibacillinum Cum Natrum Muriaticum (Escherichia Coli) 16X, Cytomegalovirus Nosode 16X, Ehrlichia Nosode 16X, Epstein-Barr Virus Nosode 15C, Herpes Simplex I & II Nosode 16X, Herpes Zoster Nosode 15C, Human Papilloma Nosode 16X, Klebsiella Pneumoniae 16X, Lac Vaccinum (Cow’s Milk) 6X, 12X, 30X, 60X, 200X, Mucor Racemosus 16X, Mycobacterium Paratuberculosis 16X, Pneumoccoccinum 16X, Silicea (Silica) 9X, Staphylococcus Aureus 16X, Streptococcus Viridans 16X.

Inactive Ingredients

INACTIVE INGREDIENTS: Alcohol USP 20%, Purified Water USP.