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.

Active Ingredient

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

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.


Structured Label Content

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.

Active Ingredient (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

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.

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.


Advanced Ingredient Data


Raw Label Data

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