Helleborus Berberis Special Order

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:10:13

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Aristolochia ex herba 3X, Berberis e fruct. 3X, Helleborus e pl. tota 3X, Alumen 4X

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

Uses

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

Warnings

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.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Organic sucrose

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com

Label Images#

HelleborusBerberisSOPellets
HelleborusBerberisSOPellets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-5036-2Helleborus Berberis Special Order1350 in 1 BOTTLE, GLASSPELLET13501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-5036HELLEBORUS BERBERIS SPECIAL ORDER PELLET [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20180605_6dd63c1f-e59e-e73f-e053-2a91aa0af677.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-503648951-5036-2

Ingredients#

Complete SPL Sections#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Aristolochia ex herba 3X, Berberis e fruct. 3X, Helleborus e pl. tota 3X, Alumen 4X

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Organic sucrose

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

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.

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com

Source Document#

Source XML