URI-CONTROL RX - atropa belladonna, apis mellifera, silver nitrate, lytta vesicatoria, equisetum hyemale, pulsatilla vulgaris, smilax regelii root, causticum, petroselinum crispum and turpentine oil tablet
Heel 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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Uri-Control Rx

DESCRIPTION

Each 300 mg tablet contains as active ingredients: Belladonna 4X, Apis mellifica 6X, Argentum nitricum 6X, Cantharis 6X, Equisetum hyemale 6X, Pulsatilla 6X, Sarsaparilla 6X, Causticum 8X, Petroselinum sativum 8X, Terebinthina 8X 30 mg each. Inactive ingredients: Lactose, Magnesium stearate

INDICATION AND USAGE

For the treatment of:

Urinary tract infection
Albuminuria, Hematuria
Incontinence

DOSAGE AND ADMINISTRATION

Adults and children above 6 years: 1 tablet sublingually or dissolved completely in mouth 3 times daily or as directed by a physician.
Infants and children to 6 years: 1/2 the adult dosage.

WARNINGS

If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product. Keep this and all medicines out of the reach of children.

URI-CONTROL RX
atropa belladonna and apis mellifera and silver nitrate and lytta vesicatoria and equisetum hyemale and pulsatilla vulgaris and smilax regelii root and causticum and petroselinum crispum and turpentine oil and tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:50114-4422
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATROPA BELLADONNA (ATROPA BELLADONNA)	ATROPA BELLADONNA	4 [hp_X] in 300 mg
APIS MELLIFERA (APIS MELLIFERA)	APIS MELLIFERA	6 [hp_X] in 300 mg
SILVER NITRATE (SILVER CATION)	SILVER NITRATE	6 [hp_X] in 300 mg
LYTTA VESICATORIA (LYTTA VESICATORIA)	LYTTA VESICATORIA	6 [hp_X] in 300 mg
EQUISETUM HYEMALE (EQUISETUM HYEMALE)	EQUISETUM HYEMALE	6 [hp_X] in 300 mg
PULSATILLA VULGARIS (PULSATILLA VULGARIS)	PULSATILLA VULGARIS	6 [hp_X] in 300 mg
SMILAX REGELII ROOT (SMILAX REGELII ROOT)	SMILAX REGELII ROOT	6 [hp_X] in 300 mg
CAUSTICUM (CAUSTICUM)	CAUSTICUM	8 [hp_X] in 300 mg
PETROSELINUM CRISPUM (PETROSELINUM CRISPUM)	PETROSELINUM CRISPUM	8 [hp_X] in 300 mg
TURPENTINE OIL (TURPENTINE OIL)	TURPENTINE OIL	8 [hp_X] in 300 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE
MAGNESIUM STEARATE

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Tablet)	Size	9mm
Flavor		Imprint Code	BHI;O;M
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50114-4422-2	30000 mg in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/30/2011	08/20/2014

Labeler - Heel Inc (102783016)

Name	Address	ID/FEI	Business Operations
Establishment
Heel Inc		102783016	manufacture(50114-4422)

Revised: 8/2014

Document Id: 44489355-a65c-4882-b153-177c10e4a324

Set id: 99cb7acf-f9ca-4a7f-8449-eb4c6ffa7ccc

Version: 2

Effective Time: 20140825

Heel Inc