Constipation 2215P

Drug Labeling and Warnings

Drug Details [pdf]

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 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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Constipation 2215P

INDICATIONS & USAGE SECTION

Constipation  Formulated for symptoms associated with constipation such as difficult elimination, hard stools, pain, cramping, itching and bloating.

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) 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

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, Echinacea 3x, Iris versicolor 3x, Phytolacca 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with constipation such as difficult elimination, hard stools, pain, cramping, itching and bloating.

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

Package label

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 pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55714-2215
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PICEA MARIANA RESIN (UNII: 71AOV0W131) (PICEA MARIANA RESIN - UNII:71AOV0W131) PICEA MARIANA RESIN15 [hp_X]  in 1 g
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT15 [hp_X]  in 1 g
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE15 [hp_X]  in 1 g
ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE15 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 g
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL15 [hp_X]  in 1 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS15 [hp_X]  in 1 g
COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT15 [hp_X]  in 1 g
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE15 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL15 [hp_X]  in 1 g
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE15 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 g
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE15 [hp_X]  in 1 g
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK15 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED15 [hp_X]  in 1 g
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM15 [hp_X]  in 1 g
FRANGULA PURSHIANA BARK (UNII: 4VBP01X99F) (FRANGULA PURSHIANA BARK - UNII:4VBP01X99F) FRANGULA PURSHIANA BARK15 [hp_X]  in 1 g
SANICULA EUROPAEA LEAF (UNII: JYZ6110L9I) (SANICULA EUROPAEA LEAF - UNII:JYZ6110L9I) SANICULA EUROPAEA LEAF15 [hp_X]  in 1 g
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM15 [hp_X]  in 1 g
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE15 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE15 [hp_X]  in 1 g
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF15 [hp_X]  in 1 g
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT15 [hp_X]  in 1 g
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC15 [hp_X]  in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED3 [hp_X]  in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT3 [hp_X]  in 1 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 g
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-2215-128.35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
2NDC: 55714-2215-256.7 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
3NDC: 55714-2215-07.08 g 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(55714-2215)

Revised: 1/2019