Diarrhea 2260L-Dis

Drug Labeling and Warnings

Drug Details [pdf]

DIARRHEA- pyrogenium, aconitum nap., arg. nit., arsenicum alb., baptisia, bryonia, carbo veg., chamomilla, cinchona, collinsonia, colocynthis, elaterium, gelsemium, ipecac., iris versicolor, lycopodium, podoph. pelt., raphanus, tabacum, vaccinium, zingiber, aesculus hipp., juglans regia 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.

----------

Diarrhea 2260L-Dis

INDICATIONS & USAGE SECTION

Diarrhea  Formulated for symptoms of intestinal upset such as loose or liquid stools, intestinal cramping, nausea, flatulence and fatigue. 

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Pyrogenium 30x, Aconitum nap.15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bryonia 15x, Carbo veg. 15x, Chamomilla 15x, Cinchona 15x, Collinsonia 15x, Colocynthis 15x, Elaterium 15x, Gelsemium 15x, Ipecac. 15x, Iris versicolor 15x, Lycopodium 15x, Podoph. pelt. 15x, Raphanus 15x,Tabacum 15x, Vaccinium 15x, Zingiber 15x, Aesculus hipp. 3x, Juglans regia 3x.

OTC - PURPOSE SECTION

Formulated for symptoms of intestinal upset such as loose or liquid stools, intestinal cramping, nausea, flatulence and fatigue.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

DIARRHEA 
pyrogenium, aconitum nap., arg. nit., arsenicum alb., baptisia, bryonia, carbo veg., chamomilla, cinchona, collinsonia, colocynthis, elaterium, gelsemium, ipecac., iris versicolor, lycopodium, podoph. pelt., raphanus, tabacum, vaccinium, zingiber, aesculus hipp., juglans regia liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55714-2260
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [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 (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA15 [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 RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA15 [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
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP15 [hp_X]  in 1 mL
ECBALLIUM ELATERIUM FRUIT (UNII: 8P8HWT6ZWC) (ECBALLIUM ELATERIUM FRUIT - UNII:8P8HWT6ZWC) ECBALLIUM ELATERIUM FRUIT15 [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
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM15 [hp_X]  in 1 mL
RADISH (UNII: EM5RP35463) (RADISH - UNII:EM5RP35463) RADISH15 [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
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER15 [hp_X]  in 1 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT3 [hp_X]  in 1 mL
ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7) ENGLISH WALNUT3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-2260-129.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
2NDC: 55714-2260-259.14 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
3NDC: 55714-2260-00.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/201101/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2260)

Revised: 1/2019
Document Id: 914897ea-a230-348a-e053-2a95a90ae162
Set id: 2bde4f94-f82e-5676-c3f9-ef75bb5344e8
Version: 3
Effective Time: 20190131
 
Newton Laboratories, Inc.