Insomnia description, usages, side effects, indications, overdosage, supplying and lots more!

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Insomnia

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Insomnia


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Insomnia  Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Absinthium 10x, Anacardium orientale 10x, Arg. nit. 10x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Calc. carb. 10x, Camphora 10x, Chamomilla 10x, Cimicifuga 10x, Cinchona 10x, Coffea cruda 10x, Cypripedium 10x, Gelsemium 10x, Humulus 10x, Hyoscyamus 10x, Ignatia 10x, Kali brom.10x, Nux vom. 10x, Passiflora 10x, Pulsatilla 10x, Scutellaria lateriflora 10x, Sepia 10x, Thuja occ. 10x, Passiflora 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.

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

 

Insomnia

Absinthium, Anacardium orientale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana PELLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2247
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Wormwood WORMWOOD 10 [hp_X]
SEMECARPUS ANACARDIUM JUICE SEMECARPUS ANACARDIUM JUICE 10 [hp_X]
SILVER NITRATE SILVER CATION 10 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 10 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 10 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 10 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X]
CAMPHOR (NATURAL) 10 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 10 [hp_X]
BLACK COHOSH BLACK COHOSH 10 [hp_X]
Cinchona Officinalis Bark Cinchona Officinalis Bark 10 [hp_X]
ARABICA COFFEE BEAN Arabica Coffee Bean 10 [hp_X]
CYPRIPEDIUM PARVIFOLUM ROOT Cypripedium Parvifolum Root 10 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT 10 [hp_X]
HOPS HOPS 10 [hp_X]
Hyoscyamus Niger HYOSCYAMUS NIGER 10 [hp_X]
STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED 10 [hp_X]
POTASSIUM BROMIDE POTASSIUM CATION 10 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 10 [hp_X]
Passiflora Incarnata Flowering Top PASSIFLORA INCARNATA FLOWERING TOP 10 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 10 [hp_X]
Scutellaria Lateriflora SCUTELLARIA LATERIFLORA 10 [hp_X]
SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE 10 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X]
Valerian VALERIAN 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2247-1 28.35 in 1 BOTTLE, GLASS
2 NDC:55714-2247-2 56.7 in 1 BOTTLE, GLASS
3 NDC:55714-2247-0 7.08 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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