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NDC 13838-1432-01 Hedera comp. .1; .4; .15; .35 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Hedera comp. .1; .4; .15; .35 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Hedera comp. is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Phytodyne Inc.. The primary component is GLYCYRRHIZA GLABRA; HEDERA HELIX FLOWERING TWIG; MARRUBIUM VULGARE; THYME.

Product Information

NDC	13838-1432
Product ID	13838-1432_3977832e-7486-49de-a174-6cd17e62fb34
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hedera comp.
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hedera Helix Flowering Twig, Thyme, Marrubium Vulgare, and Glycyrrhiza Glabra
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	.1; .4; .15; .35
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	GLYCYRRHIZA GLABRA; HEDERA HELIX FLOWERING TWIG; MARRUBIUM VULGARE; THYME
Labeler Name	Phytodyne Inc.
Pharmaceutical Class	Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE],
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 13838-1432-01 (13838143201)

Pricing Information	N/A
NDC Package Code	13838-1432-1
Billing NDC	13838143201
Package	20 mL in 1 BOTTLE, GLASS (13838-1432-1)
Marketing Start Date	2005-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0dc44983-bf1f-43dd-8eaa-41e7c0781c9f Details

Use

For the temporary relief of cough and sinus congestion

Directions

Adults and children above 12 years: 2-5 drops 1-3 times daily in pure water before meals. Consult a physician for use in children under 12 years of age.

Ingredients

Hedera helix Ø (N) 40%, Thymus vulgaris Ø (N) 35%, Marrubium vulgare Ø (N) 15%, Glycyrrhiza glabra Ø (N) 10%

SPL UNCLASSIFIED SECTION

Alcohol: 65

TAMPER-EVIDENT

Do not use if tamper evident strip is broken from base of cap.

WARNING

Ask a doctor if you are pregnant or nursing.

Keep away from children. In case of overdose, call a medical professional.

PRINCIPAL DISPLAY PANEL - 20 ml Bottle Label

CERES®

Homeopathic Medicine

Hedera comp.

Use: For the temporary relief of cough and

sinus congestion

Directions : Adults and children above 12 years: 2-5

drops 1-3 times daily in pure water before meals. Consult

a physician for use in children under 12 years of age.

0.67 fl. oz. (20ml)

Lot#: 1234567A

EXP: 99.9999

Principal Display Panel - 20 ml Bottle Label

INGREDIENTS AND APPEARANCE

HEDERA COMP.

hedera helix flowering twig, thyme, marrubium vulgare, and glycyrrhiza glabra solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13838-1432
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HEDERA HELIX FLOWERING TWIG (UNII: 3D10KUA6BM) (HEDERA HELIX FLOWERING TWIG - UNII:3D10KUA6BM)	HEDERA HELIX FLOWERING TWIG	0.4 [hp_X] in 1 mL
THYME (UNII: CW657OBU4N) (THYME - UNII:CW657OBU4N)	THYME	0.35 [hp_X] in 1 mL
MARRUBIUM VULGARE (UNII: 7A72MUN24Z) (MARRUBIUM VULGARE - UNII:7A72MUN24Z)	MARRUBIUM VULGARE	0.15 [hp_X] in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	0.1 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13838-1432-1	20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/01/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED HOMEOPATHIC		10/01/2005

Labeler - Phytodyne Inc. (164980927)

Revised: 12/2021

Document Id: 3977832e-7486-49de-a174-6cd17e62fb34

Set id: 0dc44983-bf1f-43dd-8eaa-41e7c0781c9f

Version: 2

Effective Time: 20211213