STRESS LESS- aconitum nap., ambra, anacardium orientale, arg. nit., asafoetida, bryonia, chamomilla, cimicifuga, coffea cruda, cypripedium, gelsemium, hyoscyamus, hypericum, ignatia, kali phos., nux vom., sambucus nig., strychninum, theridion, valeriana, passiflora liquid 
Stress Less, 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.

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Stress Less

QUESTIONS SECTION

Manuractured for Stress Less, Inc., Atlanta, GA 30319

​Questions? 800-555-3783

INDICATIONS & USAGE SECTION

Stress Less: Formulated for associated symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Passiflora 3x, Valeriana 3x Aconitum nap. 15x, Ambra 15x, Anacard. or. 15x, Arg. nit. 15x, Asafoetida 15x, Bryonia 15x, Chamomilla 15x, Cimicifuga 15x, Coffea cruda 15x, Cypripedium 15x, Gelsemium 15x, Hyoscyamus 15x, Hypericum 15x, Ignatia 15x, Kali phos. 15x, Nux vom. 15x, Sambucus nig. 15x, Strychninum 15x, Theridion 15x, Valeriana 15x, .

OTC - PURPOSE SECTION

Formulated for associated symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

WARNINGS SECTION

Warning: Keep ou of reach of children. Do not use ​if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If ​pregnant or breast-feeding,​ ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If ​pregnant or breast-feeding,​ ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

STRESS LESS 
aconitum nap., ambra, anacardium orientale, arg. nit., asafoetida, bryonia, chamomilla, cimicifuga, coffea cruda, cypripedium, gelsemium, hyoscyamus, hypericum, ignatia, kali phos., nux vom., sambucus nig., strychninum, theridion, valeriana, passiflora liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67840-0001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 mL
AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C) AMBERGRIS15 [hp_X]  in 1 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE15 [hp_X]  in 1 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE15 [hp_X]  in 1 mL
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA15 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA15 [hp_X]  in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH15 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN15 [hp_X]  in 1 mL
CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFOLUM ROOT15 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER15 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM15 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED15 [hp_X]  in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC15 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED15 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP15 [hp_X]  in 1 mL
STRYCHNINE (UNII: H9Y79VD43J) (STRYCHNINE - UNII:H9Y79VD43J) STRYCHNINE15 [hp_X]  in 1 mL
THERIDION CURASSAVICUM (UNII: 9Z8D3HEM8L) (THERIDION CURASSAVICUM - UNII:9Z8D3HEM8L) THERIDION CURASSAVICUM15 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN15 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67840-0001-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/15/2018
Labeler - Stress Less, Inc. (926429432)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(67840-0001)

Revised: 1/2018
Document Id: 626f4e66-a9ad-3769-e053-2a91aa0a7116
Set id: 626f6019-93f2-6818-e053-2991aa0a33f0
Version: 1
Effective Time: 20180110
 
Stress Less, Inc.