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NDC 13838-1449-01 Alchemilla comp. .3; .21; .14; .21; .14 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Alchemilla comp. .3; .21; .14; .21; .14 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Alchemilla comp. is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Phytodyne Inc.. The primary component is ALCHEMILLA XANTHOCHLORA FLOWERING TOP; LYCOPUS EUROPAEUS WHOLE; ONION; RIBES NIGRUM LEAF; SAGE.

Product Information

NDC	13838-1449
Product ID	13838-1449_3c5d6f0e-fc3b-4b4a-b2b9-6d4b29c164fc
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	Alchemilla comp.
Proprietary Name Suffix	n/a
Non-Proprietary Name	alchemilla xanthochlora flowering top, lycopus europaeus whole, ribes nigrum leaf, sage, and onion
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	.3; .21; .14; .21; .14
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	ALCHEMILLA XANTHOCHLORA FLOWERING TOP; LYCOPUS EUROPAEUS WHOLE; ONION; RIBES NIGRUM LEAF; SAGE
Labeler Name	Phytodyne Inc.
Pharmaceutical Class	Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 13838-1449-01 (13838144901)

Pricing Information	N/A
NDC Package Code	13838-1449-1
Billing NDC	13838144901
Package	20 mL in 1 BOTTLE, GLASS (13838-1449-1)
Marketing Start Date	2005-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c5806707-4ac7-4881-ba56-05860a9b409b Details

Use

For temporary relief of menstrual discomfort

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

Alchemilla vulgaris Ø (M) 30%, Lycopus europaeus Ø (N) 21%, Ribes nigrum Ø (N) 21%, Salvia officinalis Ø (N) 14%, Allium cepa 6X (M) 14%

SPL UNCLASSIFIED SECTION

Alcohol: 55

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

Alchemilla comp.

Use: For temporary relief of menstrual discomfort

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

ALCHEMILLA COMP.

alchemilla xanthochlora flowering top, lycopus europaeus whole, ribes nigrum leaf, sage, and onion solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13838-1449
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69) (ALCHEMILLA XANTHOCHLORA FLOWERING TOP - UNII:9M289NKI69)	ALCHEMILLA XANTHOCHLORA FLOWERING TOP	0.3 [hp_X] in 1 mL
LYCOPUS EUROPAEUS WHOLE (UNII: KY18JPU7QQ) (LYCOPUS EUROPAEUS WHOLE - UNII:KY18JPU7QQ)	LYCOPUS EUROPAEUS WHOLE	0.21 [hp_X] in 1 mL
RIBES NIGRUM LEAF (UNII: Z46FSZ2M25) (RIBES NIGRUM LEAF - UNII:Z46FSZ2M25)	RIBES NIGRUM LEAF	0.21 [hp_X] in 1 mL
SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J)	SAGE	0.14 [hp_X] in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	0.14 [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:13838-1449-1	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: 3c5d6f0e-fc3b-4b4a-b2b9-6d4b29c164fc

Set id: c5806707-4ac7-4881-ba56-05860a9b409b

Version: 2

Effective Time: 20211216