COLD HANDS - FEET - histaminum hydrochloricum,thyroidinum, aconitum nap., arsenicum alb., bryonia, cactus, calc. fluor., ceanoth

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3), Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P), Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD), Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV), Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B), Selenicereus Grandiflorus Stem (UNII: 7114SV0MYK) (Selenicereus Grandiflorus Stem - UNII:7114SV0MYK), Calcium Fluoride (UNII:
Available from:
Newton Laboratories, Inc.
INN (International Name):
Histamine Dihydrochloride
Composition:
Histamine Dihydrochloride 15 [hp_X] in 1 g
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Cold Hands - Feet  Formulated for symptoms associated with circulation such as dizziness, fatigue and weakness as well as tingling, numbness or coldness in the extremities. Formulated for symptoms associated with circulation such as dizziness, fatigue and weakness as well as tingling, numbness or coldness in the extremities.
Authorization status:
unapproved homeopathic
Authorization number:
55714-2303-0, 55714-2303-1, 55714-2303-2

COLD HANDS - FEET - histaminum hydrochloricum,thyroidinum, aconitum nap., arsenicum

alb., bryonia, cactus, calc. fluor., ceanothus, cinchona, convallaria, digitalis, gelsemium,

glonoinum, hydrocoyle, kali carb., lachesis, naja, nat carb., nat mur., nux vom., phosphorus,

pullsatilla, rhus toxicodendron, strophanthus hispidus, sulphur, echinacea pellet

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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Cold Hands - Feet

INDICATIONS & USAGE SECTION

Cold Hands - Feet Formulated for symptoms associated with circulation such as dizziness, fatigue and

weakness as well as tingling, numbness or coldness in the extremities.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 pellets orally one to four times daily or as directed by a healthcare

professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Histaminum hydrochloricum 15x,Thyroidinum 15x, Aconitum nap. 10x, Arsenicum alb. 10x, Bryonia

10x, Cactus 10x, Calc. fluor. 10x, Ceanothus 10x, Cinchona 10x, Convallaria 10x, Digitalis 10x,

Gelsemium 10x, Glonoinum 10x, Hydrocotyle 10x, Kali carb. 10x, Lachesis 10x, Naja 10x, Nat. carb.

10x, Nat. mur. 10x, Nux vom. 10x, Phosphorus 10x, Pulsatilla 10x, Rhus toxicodendron 10x,

Strophanthus hispidus 10x, Sulphur 10x, Echinacea 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with circulation such as dizziness, fatigue and weakness as well as

tingling, numbness or coldness in the extremities.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

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

COLD HANDS - FEET

histaminum hydrochloricum,thyroidinum, aconitum nap., arsenicum alb., bryonia, cactus, calc. fluor., ceanothus,

cinchona, convallaria, digitalis, gelsemium, glonoinum, hydrocoyle, kali carb., lachesis, naja, nat carb., nat mur.,

nux vom., phosphorus, pullsatilla, rhus toxicodendron, strophanthus hispidus, sulphur, echinacea pellet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55714-230 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Hista mine Dihydro chlo ride (UNII: 3POA0 Q6 44U) (Histamine - UNII:8 20 48 4N8 I3)

Histamine Dihydro chlo ride

15 [hp_X]

in 1 g

Thyro id, Unspecified (UNII: 0 B4FDL9 I6 P) (Thyro id, Unspecified - UNII:0 B4FDL9 I6 P)

Thyro id, Unspecified

15 [hp_X]

in 1 g

Aco nitum Na pellus (UNII: U0 NQ8 555JD) (Aco nitum Napellus - UNII:U0 NQ8 555JD)

Aco nitum Napellus

10 [hp_X]

in 1 g

Arsenic Trio xide (UNII: S7V9 2P6 7HO) (Arsenic Catio n (3+) - UNII:C9 6 6 13F5AV)

Arsenic Trio xide

10 [hp_X]

in 1 g

Bryo nia Alba Ro o t (UNII: T7J0 46 YI2B) (Bryo nia Alba Ro o t - UNII:T7J0 46 YI2B)

Bryo nia Alba Ro o t

10 [hp_X]

in 1 g

Selenicereus Gra ndiflo rus Stem (UNII: 7114SV0 MYK) (Selenicereus Grandiflo rus Stem -

UNII:7114SV0 MYK)

Selenicereus Grandiflo rus

Ste m

10 [hp_X]

in 1 g

Ca lcium Fluo ride (UNII: O3B55K4YKI) (Fluo ride Io n - UNII:Q8 0 VPU40 8 O)

Calcium Fluo ride

10 [hp_X]

in 1 g

Cea no thus America nus Lea f (UNII: 25B1Y14T8 N) (Ceano thus Americanus Leaf -

UNII:25B1Y14T8 N)

Ceano thus Americanus

Le a f

10 [hp_X]

in 1 g

Cincho na O fficina lis Ba rk (UNII: S0 0 3A158 SB) (Cincho na Officinalis Bark -

UNII:S0 0 3A158 SB)

Cincho na Officinalis Bark

10 [hp_X]

in 1 g

Co nva lla ria Ma j a lis (UNII: QHH4HVF5QE) (Co nvallaria Majalis - UNII:QHH4HVF5QE)

Co nvallaria Majalis

10 [hp_X]

in 1 g

Dig ita lis (UNII: F1T8 QT9 U8 B) (Digitalis - UNII:F1T8 QT9 U8 B)

Digita lis

10 [hp_X]

in 1 g

Gelsemium Sempervirens Ro o t (UNII: 6 39 KR6 0 Q1Q) (Gelsemium Sempervirens Ro o t -

UNII:6 39 KR6 0 Q1Q)

Gelsemium Sempervirens

Ro o t

10 [hp_X]

in 1 g

Nitro g lycerin (UNII: G59 M7S0 WS3) (Nitro glycerin - UNII:G59 M7S0 WS3)

Nitro glyc e rin

10 [hp_X]

in 1 g

Centella Asia tica (UNII: 7M8 6 7G6 T1U) (Centella Asiatica - UNII:7M8 6 7G6 T1U)

Centella Asiatica

10 [hp_X]

in 1 g

Po ta ssium Ca rbo na te (UNII: BQN1B9 B9 HA) (Carbo nate Io n - UNII:7UJQ5OPE7D)

Po tassium Carbo nate

10 [hp_X]

in 1 g

La chesis Muta Veno m (UNII: VSW71SS0 7I) (Lachesis Muta Veno m - UNII:VSW71SS0 7I)

Lachesis Muta Veno m

10 [hp_X]

in 1 g

Na j a Na j a Veno m (UNII: ZZ4AG7L7VM) (Naja Naja Veno m - UNII:ZZ4AG7L7VM)

Naja Naja Veno m

10 [hp_X]

in 1 g

So dium Ca rbo na te (UNII: 45P326 1C7T) (Carbo nate Io n - UNII:7UJQ5OPE7D)

So dium Carbo nate

10 [hp_X]

in 1 g

So dium Chlo ride (UNII: 451W47IQ8 X) (Chlo ride Io n - UNII:Q32ZN48 6 9 8 )

So dium Chlo ride

10 [hp_X]

in 1 g

Strychno s Nux-vo mica Seed (UNII: 26 9 XH139 19 ) (Strychno s Nux-vo mica Seed -

UNII:26 9 XH139 19 )

Strychno s Nux-vo mica

Se e d

10 [hp_X]

in 1 g

Pho spho rus (UNII: 27YLU75U4W) (Pho spho rus - UNII:27YLU75U4W)

Pho spho rus

10 [hp_X]

in 1 g

Pulsa tilla Vulg a ris (UNII: I76 KB35JEV) (Pulsatilla Vulgaris - UNII:I76 KB35JEV)

Pulsatilla Vulgaris

10 [hp_X]

in 1 g

To xico dendro n Pubescens Lea f (UNII: 6 IO18 2RP7A) (To xico dendro n Pubescens Leaf -

UNII:6 IO 18 2RP7A)

To xico dendro n Pubescens

Le a f

10 [hp_X]

in 1 g

Stro pha nthus Hispidus Seed (UNII: MO8 9 2VI77K) (Stro phanthus Hispidus Seed -

UNII:MO8 9 2VI77K)

Stro phanthus Hispidus

Se e d

10 [hp_X]

in 1 g

Sulfur (UNII: 70 FD1KFU70 ) (Sulfur - UNII:70 FD1KFU70 )

S ulfur

10 [hp_X]

in 1 g

Echina cea , Unspecified (UNII: 4N9 P6 CC1DX) (Echinacea, Unspecified -

UNII:4N9 P6 CC1DX)

Echinacea, Unspecified

3 [hp_X]

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Sucro se (UNII: C151H8 M554)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55714-230 3-1

28 .35 g in 1 BOTTLE, GLASS

2

NDC:55714-230 3-2

56 .7 g in 1 BOTTLE, GLASS

3

NDC:55714-230 3-0

7.0 8 g in 1 BOTTLE, GLASS

Newton Laboratories, Inc.

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 3/0 1/20 11

Labeler -

Newton Laboratories, Inc. (788793610)

Registrant -

Newton Laboratories, Inc. (788793610)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Newto n Labo rato ries, Inc.

78 8 79 36 10

MANUFACTURE(55714-230 3)

Revised: 3/2011

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