Cold - Sinus description, usages, side effects, indications, overdosage, supplying and lots more!

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Cold - Sinus

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Cold - Sinus


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Cold -  Sinus  Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

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

Influenzinum 30x, Aralia quin. 15x, Arsenicum alb. 15x, Bryonia 15x, Euphrasia 15x, Gaultheria 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Sabadilla 15x, Salvia 15x, Sticta 15x, Verbascum 15x, Echinacea 3x, Hydrastis 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

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

Cold - Sinus

Influenza A Virus, Influenza B Virus, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procubens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2204
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS Influenza A Virus 30 [hp_X]
AMERICAN GINSENG American Ginseng 15 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 15 [hp_C]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
EUPHRASIA STRICTA EUPHRASIA STRICTA 15 [hp_X]
Gaultheria Procumbens Top Gaultheria Procumbens Top 15 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 15 [hp_X]
HISTAMINE DIHYDROCHLORIDE Histamine 15 [hp_X]
GOLDENSEAL GOLDENSEAL 15 [hp_X]
POTASSIUM DICHROMATE DICHROMATE ION 15 [hp_X]
MERCURY Mercury 15 [hp_X]
PHOSPHORUS PHOSPHORUS 15 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 15 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 15 [hp_X]
SCHOENOCAULON OFFICINALE SEED SCHOENOCAULON OFFICINALE SEED 15 [hp_X]
SAGE 15 [hp_X]
LOBARIA PULMONARIA LOBARIA PULMONARIA 15 [hp_X]
VERBASCUM THAPSUS VERBASCUM THAPSUS 15 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
INFLUENZA B VIRUS Influenza B Virus 30 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2204-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-2204-2 59.14 in 1 BOTTLE, GLASS
3 NDC:55714-2204-0 .5 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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