PASSIFLORA CRATAEGUS- passiflora crataegus liquid Uriel Pharmacy Inc. 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. ---------- Passiflora Crataegus Directions: FOR ORAL USE. Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow. Active Ingredients: Bryophyllum (Life plant) 2X, Crataegus (Hawthorn) 3X, Passiflora (Passionflower) 3X, Salix vitellina (Golden willow) 3X Inactive Ingredients: Water, Salt Use: Temporary relief of headache. KEEP OUT OF REACH OF CHILDREN. Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com PASSIFLORA CRATAEGUS passiflora crataegus liquid Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:48 9 51-8 0 11 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KALANCHO E DAIGREMO NTIANA LEAF (UNII: L6 X13JKL8 O) (KALANCHOE KALANCHOE 2 [hp_X] DAIGREMONTIANA LEAF - UNII:L6 X13JKL8 O) DAIGREMONTIANA LEAF in 1 mL HAWTHO RN LEAF WITH FLO WER (UNII: 6 OM0 9 RPY36 ) (HAWTHORN LEAF WITH HAWTHORN LEAF WITH 3 [hp_X] FLOWER - UNII:6 OM0 9 RPY36 ) FLOWER in 1 mL PASSIFLO RA INCARNATA FLO WERING TO P (UNII: CLF5YFS11O) (PASSIFLORA PASSIFLORA INCARNATA 3 [hp_X] INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) FLOWERING TOP in 1 mL SALIX ALBA FLO WER (UNII: 9 0 5Y746 BSW) (SALIX ALBA FLOWER - 3 [hp_X] SALIX ALBA FLOWER UNII:9 0 5Y746 BSW) in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 0 59 QF0 KO0 R) SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48 9 51-8 0 11-1 10 in 1 BOX 0 9 /0 1/20 0 9 1 1 mL in 1 AMPULE; Type 1: Co nvenience Kit o f Co -Package Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date unappro ved ho meo pathic 0 9 /0 1/20 0 9 Labeler - Uriel Pharmacy Inc. (043471163) Establishment Name Addre ss ID/FEI Busine ss Ope rations Uriel Pharmacy Inc. 0 4347116 3 manufacture(48 9 51-8 0 11) Revised: 5/2018 Uriel Pharmacy Inc..