Label: SPRAYOLOGY STRESS RELIEF- agnus castus, avena sativa, cinchona officinalis, humulus lupulus, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61096-0006-1 - Packager: Eight and Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 February 26, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
- Adults and children over 12: 2 sprays into the mouth each 60 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter.
- Ages 2 to 12: 1 spray into the mouth each 60 minutes as needed for symptom relief the first day, 1 spray 3 times a day thereafter.
- Under age 2: consult a health care professional.
- PURPOSE
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPRAYOLOGY STRESS RELIEF
agnus castus, avena sativa, cinchona officinalis, humulus lupulus, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61096-0006 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE 6 [hp_X] in 41 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 1 [hp_X] in 41 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 6 [hp_X] in 41 mL HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 2 [hp_X] in 41 mL HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 200 [hp_C] in 41 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 200 [hp_C] in 41 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X] in 41 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 3 [hp_X] in 41 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61096-0006-1 1 in 1 CARTON 1 41 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/26/2014 Labeler - Eight and Company (927364120) Registrant - Eight and Company (927364120)