Helleborus Comp. A

Helleborus Comp. A
SPL v2
SPL
SPL Set ID 150ea693-e713-aad2-e063-6394a90a2c34
Route
ORAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Formica Rufa (6 [hp_X]) Antimony (8 [hp_X]) Silver (3 [hp_X]) Helleborus Foetidus Root (17 [hp_X]) Phosphate Ion (12 [hp_X]) Arsenic Cation (3+) (7 [hp_X]) Tin (20 [hp_X]) Phosphorus Juglans Regia Leaf Lead
Inactive Ingredients
Water Lactose, Unspecified Form Sodium Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2009-09-01

Description

Directions: FOR ORAL USE ONLY.


Medication Information

Warnings and Precautions

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains traces of lactose. 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.

Indications and Usage

Directions: FOR ORAL USE ONLY.

Dosage and Administration

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

Description

Directions: FOR ORAL USE ONLY.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Inactive Ingredients: Water, Salt, Lactose

Prepared using rhythmical processes.

Section 51945-4

Section 55105-1

Use: Temporary relief of headache.

Section 55106-9

Active Ingredients: Helleborus e pl. tota (christmas rose) 3X, Formica (red wood ant) 6X, Kalium phos. (potassium dihydrogenphosphate) 6X, Stibium met (antimony) 6X, Juglans reg. e fol. et fruct (walnut) 7X, Argentum met (silver) 8X, Phosphorus (yellow phosphorus) 12X, Stannum met. (metallic tin) 12X, Arsenicum album (white arsenic) 17X, Plumbum Silicicum (lead silicate) 20X


Structured Label Content

Indications and Usage (34067-9)

Directions: FOR ORAL USE ONLY.

Dosage and Administration (34068-7)

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

Warnings and Precautions (34071-1)

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains traces of lactose. 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.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive Ingredients: Water, Salt, Lactose

Prepared using rhythmical processes.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Use: Temporary relief of headache.

Section 55106-9 (55106-9)

Active Ingredients: Helleborus e pl. tota (christmas rose) 3X, Formica (red wood ant) 6X, Kalium phos. (potassium dihydrogenphosphate) 6X, Stibium met (antimony) 6X, Juglans reg. e fol. et fruct (walnut) 7X, Argentum met (silver) 8X, Phosphorus (yellow phosphorus) 12X, Stannum met. (metallic tin) 12X, Arsenicum album (white arsenic) 17X, Plumbum Silicicum (lead silicate) 20X


Advanced Ingredient Data


Raw Label Data

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