NDC | 69676-0008-1 |
Set ID | 7900262d-90fd-6c08-e053-2991aa0a77f9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Genexa Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
-
ACTIVE INGREDIENT
Active ingredients** (in each tablet)
Aconitum napellus ‡ 12X HPUS
Calcarea phosphorica 8X HPUS
Chamomilla ‡ 6X HPUS
Gelsemium sempervirens ‡ 12X HPUS
Ignatia amara ‡ 12X HPUS
Kali carbonicum 8X HPUS
Passiflora incarnata ‡ 3X HPUS
Valeriana officinalis ‡ 3X HPUS
‡ Certified Organic
"HPUS" indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
-
SPL UNCLASSIFIED SECTION
THE Genexa® PLEDGE
WE PLEDGE TO DELIVER THE HIGHEST QUALITY MEDICINES.
All our products are made with clean, certified organic and non-GMO Ingredients.
Genexa products maintain the highest standards in manufacturing and are made in the USA with globally sourced organic ingredients.
We pioneered the organic technology (patent pending) that eliminates harmful synthetics from our proprietary chewable tablet.
Our products are free of artificial dyes, flavors and preservatives.
Distributed by: Genexa Inc.
Beverly Hills, CA 90211
www.genexa.com
Certified Organic by SCS Global Services
- OTHER SAFETY INFORMATION
-
SPL UNCLASSIFIED SECTION
Genexa®
THE HEALTHIER MEDICINE®
Genexa was founded on the belief that medicine should not only be UNQUESTIONABLY SAFE, but that it should be HEALTHY for you and your family.
We're also very proud to be a Certified B Corporation using business as a force for good.
Questions? Comments?
1-855-GENEXA-1
hello@genexa.com
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CALM KEEPER
aconitum napellus, calcarea phosphorica, chamomilla, gelsemium sepervirens, ignatia amara, kali carbonicum, passiflora incarnata, valeriana officinalis tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69676-0008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 8 [hp_X] MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S) MATRICARIA CHAMOMILLA WHOLE 6 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 12 [hp_X] STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 12 [hp_X] POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 8 [hp_X] VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 3 [hp_X] PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X] ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 12 [hp_X] Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) MALTODEXTRIN (UNII: 7CVR7L4A2D) RICE BRAN (UNII: R60QEP13IC) DEXTROSE (UNII: IY9XDZ35W2) Product Characteristics Color white (Off-white) Score no score Shape ROUND Size 10mm Flavor VANILLA (Lavender) Imprint Code G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69676-0008-1 1 in 1 CARTON 07/20/2018 08/01/2023 1 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/20/2018 08/01/2023 Labeler - Genexa Inc. (079751024)