Bowel 2393P-Dis

Drug Labeling and Warnings

Drug Details [pdf]

BOWEL - DIGESTIVE CARE- bismuthum metallicum, antimon.crud., arg. nit., arsenicum alb., baptisia, bryonia, chamomilla, cinchona, iris versicolor, kali bic., lachesis, lycopodium, mag. carb., nux vom., phosphorus, podoph. pelt., pulsatilla, raphanus, rhus toxicodendron, tabacum, verbascum, zingiber, echinacea, juglans regia. 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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Bowel 2393P-Dis

OTC - PURPOSE SECTION


Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping, pressure and other related symptoms.

INACTIVE INGREDIENT SECTION

Gluten-free, non-GMO, organc beet-derived sucrose (lactrose-free) pellets.

QUESTIONS SECTION

newtonlabs.net - Question? 800 448-7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep our of reach of childdren.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

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 a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, take 3 pellets) 15 minutes before meals or as needed or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Juglans reg. 6x, Antimon.crud. 10x, Arg. nit. 10x, Baptisia 10x, Bryonia 10x, Chamomilla 10x, Cinchona 10x, Iris ver. 10x, Kali bic. 10x, Lachesis 10x, Lycopodium 10x, Mag. carb. 10x, Phos. 10x, Podoph. pelt. 10x, Pulsatilla 10x, Raphanus 10x, Rhus tox. 10x, Tabacum 10x, Verbascum 10x, Zingiber 10x, Arsenicum alb. 15x, Bismuth. met. 15x, Nux vom. 15x.

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping, pressure and other related symptoms.

PACKAGE LABEL.

package label

BOWEL - DIGESTIVE CARE 
bismuthum metallicum, antimon.crud., arg. nit., arsenicum alb., baptisia, bryonia, chamomilla, cinchona, iris versicolor, kali bic., lachesis, lycopodium, mag. carb., nux vom., phosphorus, podoph. pelt., pulsatilla, raphanus, rhus toxicodendron, tabacum, verbascum, zingiber, echinacea, juglans regia. pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55714-2393
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]  in 1 g
BISMUTH (UNII: U015TT5I8H) (BISMUTH - UNII:U015TT5I8H) BISMUTH15 [hp_X]  in 1 g
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE10 [hp_X]  in 1 g
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE10 [hp_X]  in 1 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 g
BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA10 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT10 [hp_X]  in 1 g
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE10 [hp_X]  in 1 g
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM10 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 1 g
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE10 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED15 [hp_M]  in 1 g
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 1 g
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM10 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 1 g
RADISH (UNII: EM5RP35463) (RADISH - UNII:EM5RP35463) RADISH10 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 1 g
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF10 [hp_X]  in 1 g
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS10 [hp_X]  in 1 g
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER10 [hp_X]  in 1 g
ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7) ENGLISH WALNUT6 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-2393-128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/201907/01/2019
2NDC: 55714-2393-248 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/201907/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/201907/01/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2393)

Revised: 9/2019
Document Id: 924a4ff8-77c5-e69d-e053-2a95a90a9272
Set id: 79a14ec0-d323-52ad-e053-2a91aa0aa618
Version: 3
Effective Time: 20190911