Constipation: Homeopathic Product Information

CONSTIPATION- krameria lappacea root, picea mariana resin, horse chestnut, aloe, aluminum oxide, bryonia alba root, activated charcoal, chelidonium majus, collinsonia canadensis root, graphite, goldenseal, potassium carbonate, lycopodium clavatum spore, magnesium chloride, daphne mezereum bark, strychnos nux-vomica seed, podophyllum, sanicula europaea leaf, selenium, sepia officinalis juice, silicon dioxide, tobacco leaf, veratrum album root, zinc, echinacea, unspecified, iris versicolor root, phytolacca americana root and taraxacum officinale 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.

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with acute or chronic constipation due to conditions as a poor diet, pregnancy, inactivity and muscle weakness.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC — ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Iris vers. 6x, Phytolacca 6x, Taraxacum 6x, Abies nig. 15x, Aesculus hipp. 15x, Aloe 15x, Alumina 15x, Bryonia 15x, Carbo veg. 15x, Chelidonium majus 15x, Collinsonia 15x, Graphites 15x, Hydrastis 15x, Kali carb. 15x, Lycopodium 15x, Mag. mur. 15x, Mezereum 15x, Nux vom. 15x, Podoph. pelt. 15x, Rhamnus purshiana 15x, Sanicula 15x, Selenium 15x, Sepia 15x, Silicea 15x, Tabacum 15x, Veratrum alb. 15x, Zinc.met. 15x.

OTC — PURPOSE SECTION

Formulated for symptoms associated with acute or chronic constipation due to conditions as a poor diet, pregnancy, inactivity and muscle weakness.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net — Questions? 800.448.7256

Newton Laboratoires, Inc. 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 , as 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

Keep out of reach of children.

PACKAGE LABEL

package label
(click image for full-size original)

CONSTIPATION
abies nig., aesculus hipp., aloe, alumina, bryonia, carbo veg., chelidonium majus, collinsonia , graphites, hydrastis, kali carb., lycopodium, mag. mur., mezereum, nux vom., podoph. pelt., rhamnus purshiana, sanicula, selenium, sepia, silicea, tabacum, veratrum alb., zinc.met., echinacea, iris versicolor, phytolacca, taraxacum liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4764
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KRAMERIA LAPPACEA ROOT (KRAMERIA LAPPACEA ROOT) KRAMERIA LAPPACEA ROOT 15 [hp_X] in 1 mL
PICEA MARIANA RESIN (PICEA MARIANA RESIN) PICEA MARIANA RESIN 15 [hp_X] in 1 mL
HORSE CHESTNUT (HORSE CHESTNUT) HORSE CHESTNUT 15 [hp_X] in 1 mL
ALOE (ALOE) ALOE 15 [hp_X] in 1 mL
ALUMINUM OXIDE (ALUMINUM OXIDE) ALUMINUM OXIDE 15 [hp_X] in 1 mL
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL
ACTIVATED CHARCOAL (ACTIVATED CHARCOAL) ACTIVATED CHARCOAL 15 [hp_X] in 1 mL
CHELIDONIUM MAJUS (CHELIDONIUM MAJUS) CHELIDONIUM MAJUS 15 [hp_X] in 1 mL
COLLINSONIA CANADENSIS ROOT (COLLINSONIA CANADENSIS ROOT) COLLINSONIA CANADENSIS ROOT 15 [hp_X] in 1 mL
GRAPHITE (GRAPHITE) GRAPHITE 15 [hp_X] in 1 mL
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 15 [hp_X] in 1 mL
POTASSIUM CARBONATE (CARBONATE ION) POTASSIUM CARBONATE 15 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 15 [hp_X] in 1 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 15 [hp_X] in 1 mL
DAPHNE MEZEREUM BARK (DAPHNE MEZEREUM BARK) DAPHNE MEZEREUM BARK 15 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 mL
PODOPHYLLUM (PODOPHYLLUM) PODOPHYLLUM 15 [hp_X] in 1 mL
SANICULA EUROPAEA LEAF (SANICULA EUROPAEA LEAF) SANICULA EUROPAEA LEAF 15 [hp_X] in 1 mL
SELENIUM (SELENIUM) SELENIUM 15 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 15 [hp_X] in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 15 [hp_X] in 1 mL
TOBACCO LEAF (TOBACCO LEAF) TOBACCO LEAF 15 [hp_X] in 1 mL
VERATRUM ALBUM ROOT (VERATRUM ALBUM ROOT) VERATRUM ALBUM ROOT 15 [hp_X] in 1 mL
ZINC (ZINC) ZINC 15 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL
IRIS VERSICOLOR ROOT (IRIS VERSICOLOR ROOT) IRIS VERSICOLOR ROOT 6 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT) PHYTOLACCA AMERICANA ROOT 6 [hp_X] in 1 mL
TARAXACUM OFFICINALE (TARAXACUM OFFICINALE) TARAXACUM OFFICINALE 6 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55714-4764-1 30 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/02/2019
Labeler — Newton Laboratories, Inc. (788793610)
Registrant — Newton Laboratories, Inc. (788793610)
Establishment
Name Address ID/FEI Operations
Newton Laboratories, Inc. 788793610 manufacture (55714-4764)

Revised: 12/2020 Newton Laboratories, Inc.

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