FDA.reportPublic FDA data

Chamomilla Belladonna

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:10:09

Label at a glance#

ProductChamomilla Belladonna
Active ingredientTOBACCO LEAF, MATRICARIA RECUTITA, ATROPA BELLADONNA
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Chamomilla 3X, Atropa belladonna (Nightshade) 6X, Nicotiana (Tobacco) 6X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Organic sucrose

OTC - PURPOSE SECTION

Uses: Temporary relief of cramps, or for teething symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ChamomillaBelladonnaPelletsChamomillaBelladonnaPellets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-3223-2Chamomilla Belladonna1350 in 1 BOTTLE, GLASSPELLET13501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-3223CHAMOMILLA BELLADONNA PELLET [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20180601_6d997973-201f-5b58-e053-2a91aa0a21c3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-322348951-3223-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOBACCO LEAF6YR2608RSUACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
SUCROSEC151H8M554IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6d997973-2020-5b58-e053-2a91aa0a21c36d997973-201f-5b58-e053-2a91aa0a21c32018-06-01WarningsExact identifier
spl id: 6d997973-2020-5b58-e053-2a91aa0a21c3
spl set id: 6d997973-201f-5b58-e053-2a91aa0a21c3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.