DIARRHEA- aesculus hippocastanum, juglans regia, valeriana officinalis, aconitum napellus, argentum nitricum, arsenicum album, baptisia tinctoria, bryonia, carbo vegetabilis, chamomilla, cinchona officinalis, collinsonia canadensis, colocynthis, elaterium, gelsemium sempervirens, ipecacuanha, iris versicolor, lycopodium clavatum, magnesia carbonica, phosphorus, podophyllum peltatum, rheum, sulphur, tabacum, vaccinium myrtillus liquid 
Newton Laboratories, 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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Diarrhea 1525L

INDICATIONS AND USAGE SECTION

Formulated for associated symptoms such as loose or liquid stools, cramping, gas, nausea, irritation and fatigue.

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Aesculus hippocastanum 6x, Juglans regia 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Argentum nitricum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bryonia 15x, Carbo vegetabilis 15x, Chamomilla 15x, Cinchona officinalis 15x, Collinsonia canadensis 15x, Colocynthis 15x, Elaterium 15x, Gelsemium sempervirens 15x, Ipecacuanha 15x, Iris versicolor 15x, Lycopodium clavatum 15x, Magnesia carbonica 15x, Phosphorus 15x, Podophyllum peltatum 15x, Rheum 15x, Sulphur 15x, Tabacum 15x, Vaccinium myrtillus 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as loose or liquid stools, cramping, gas, nausea, irritation and fatigue.

INACTIVE INGREDIENT SECTION

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out 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

WARNINGS: Keep out 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.

PACKAGE LABEL

package label

DIARRHEA 
aesculus hippocastanum, juglans regia, valeriana officinalis, aconitum napellus, argentum nitricum, arsenicum album, baptisia tinctoria, bryonia, carbo vegetabilis, chamomilla, cinchona officinalis, collinsonia canadensis, colocynthis, elaterium, gelsemium sempervirens, ipecacuanha, iris versicolor, lycopodium clavatum, magnesia carbonica, phosphorus, podophyllum peltatum, rheum, sulphur, tabacum, vaccinium myrtillus liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1525
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT6 [hp_X]  in 1 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP15 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE15 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT15 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL15 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA15 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK15 [hp_X]  in 1 mL
COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT15 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC15 [hp_X]  in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT15 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE15 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM15 [hp_X]  in 1 mL
RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M) RHEUM OFFICINALE ROOT15 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR15 [hp_X]  in 1 mL
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF15 [hp_X]  in 1 mL
BILBERRY (UNII: 9P2U39H18W) (BILBERRY - UNII:9P2U39H18W) BILBERRY15 [hp_X]  in 1 mL
ECBALLIUM ELATERIUM FRUIT (UNII: 8P8HWT6ZWC) (ECBALLIUM ELATERIUM FRUIT - UNII:8P8HWT6ZWC) ECBALLIUM ELATERIUM FRUIT15 [hp_X]  in 1 mL
JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-1525-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-1525)

Revised: 1/2020
Document Id: 9d732596-4e9d-55b4-e053-2995a90af5ba
Set id: 9d7322da-c2fb-0fc3-e053-2a95a90ac70b
Version: 1
Effective Time: 20200131
 
Newton Laboratories, Inc.