SPL v5
SPL
SPL Set ID d6a82455-1d03-116b-e053-2995a90ac60d
Route
ORAL
Published
Effective Date 2024-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Picea Abies Whole (1 [hp_X]) Cinchona Officinalis Bark (5 [hp_X]) Ipecac (7 [hp_X]) Atropa Belladonna (4 [hp_X]) Veratrum Album Root Mephitis Mephitis Anal Gland Fluid Protortonia Cacti Petasites Hybridus Root Sloe Helleborus Niger Root Drosera Rotundifolia Plantago Lanceolata Whole
Inactive Ingredients
Sucrose Water Vanilla Beet Top Citric Acid Monohydrate Cherry

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-01-12

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.

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.

SHAKE WELL BEFORE USE. REFRIGERATE AFTER OPENING. BEST WHEN USED WITHIN 90 DAYS OF OPENING.

Indications and Usage

Directions: FOR ORAL USE ONLY.

Dosage and Administration

Take up to every hour as needed. Ages 12 and older: 1 tablespoon. Ages 4-11: 1 teaspoon. Under age 4: Consult a doctor.

Description

Directions: FOR ORAL USE ONLY.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Inactive Ingredients: Spring water, Organic cane sugar, Cherry flavor, Beet root powder, Distilled water, Organic vanilla extract, Citric acid

Prepared using rhythmical processes.

Section 51945-4

Section 53413-1

Questions? Call 866.642.2858

Made with care by Uriel, East Troy, WI 53120

shopuriel.com Lot:

Section 55105-1

Uses: Temporary relief of cough and chest congestion.

Section 55106-9

Active Ingredients: 100 gm contains: 30 gm Plantago (ribwort plantain) 1X, 15 gm Picea abies (spruce) 1X, 2.5 gm Petasites (butterbur) 1X, 2.5 gm Prunus (blackthorn) 1X; Drosera (sundew) 4X, Atropa belladonna (nightshade) 5X, China (peruvian bark) 5X, Coccus cacti (cochineal bug, female) 5X, Helleborus (christmas rose) 5X, |pecacuanha (ipecac) 5X, Veratrum (white hellebore) 5X, Mephitis (secretion from the rectal gland of skunk) 7X


Structured Label Content

Indications and Usage (34067-9)

Directions: FOR ORAL USE ONLY.

Dosage and Administration (34068-7)

Take up to every hour as needed. Ages 12 and older: 1 tablespoon. Ages 4-11: 1 teaspoon. Under age 4: Consult a doctor.

Warnings and Precautions (34071-1)

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

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.

SHAKE WELL BEFORE USE. REFRIGERATE AFTER OPENING. BEST WHEN USED WITHIN 90 DAYS OF OPENING.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive Ingredients: Spring water, Organic cane sugar, Cherry flavor, Beet root powder, Distilled water, Organic vanilla extract, Citric acid

Prepared using rhythmical processes.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 866.642.2858

Made with care by Uriel, East Troy, WI 53120

shopuriel.com Lot:

Section 55105-1 (55105-1)

Uses: Temporary relief of cough and chest congestion.

Section 55106-9 (55106-9)

Active Ingredients: 100 gm contains: 30 gm Plantago (ribwort plantain) 1X, 15 gm Picea abies (spruce) 1X, 2.5 gm Petasites (butterbur) 1X, 2.5 gm Prunus (blackthorn) 1X; Drosera (sundew) 4X, Atropa belladonna (nightshade) 5X, China (peruvian bark) 5X, Coccus cacti (cochineal bug, female) 5X, Helleborus (christmas rose) 5X, |pecacuanha (ipecac) 5X, Veratrum (white hellebore) 5X, Mephitis (secretion from the rectal gland of skunk) 7X


Advanced Ingredient Data


Raw Label Data

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