UPELVA by PEKANA Naturheilmittel GmbH UPELVA™

UPELVA by

Drug Labeling and Warnings

UPELVA by is a Homeopathic medication manufactured, distributed, or labeled by PEKANA Naturheilmittel GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UPELVA- cyclamen purpurascens tuber, chamaelirium luteum root, hypericum perforatum, potassium carbonate, delphinium staphisagria seed, datura stramonium flowering top, viburnum opulus bark, and zanthoxylum americanum bark solution/ drops 
PEKANA Naturheilmittel GmbH

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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UPELVA™

Ingredients:
Cyclamen europaeum	3X
Datura stramonium (Stramonium)	10X
Delphinium staphysagria (Staphisagria)	4X
Chamaelirium luteum (Helonias dioica)	4X
Hypericum perforatum	2X
Kalium carbonicum	4X
Zanthoxylum fraxineum (Xanthoxylum fraxineum)	3X
Viburnum opulus	1X

Selected ingredients prepared by spagyric processes.

Contains 44% alcohol by volume.

Indications

For relief of menstrual symptoms and pain. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

Warning

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

Keep out of the reach of children.

Protect from light and heat.

Tamper Evident

Do not use this product if tamper evident strip is broken or removed from base of cap.

To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

Distributed by:
BioResource Inc.
Cotati, CA 94931

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

UPELVA™
Oral Drops

Homeopathic Medicine

For relief of menstrual
symptoms and pain

1.7 FL OZ
(50 ml)

PEKANA®

UPELVA 
cyclamen purpurascens tuber, chamaelirium luteum root, hypericum perforatum, potassium carbonate, delphinium staphisagria seed, datura stramonium flowering top, viburnum opulus bark, and zanthoxylum americanum bark solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59469-145
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cyclamen Purpurascens Tuber (UNII: G728143D8Q) (Cyclamen purpurascens Tuber - UNII:G728143D8Q)	Cyclamen Purpurascens Tuber	3 [hp_X]  in 50 mL
Chamaelirium luteum Root (UNII: DQV54Y5H3U) (Chamaelirium Luteum Root - UNII:DQV54Y5H3U)	Chamaelirium luteum Root	4 [hp_X]  in 50 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB)	Hypericum Perforatum	2 [hp_X]  in 50 mL
Potassium carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D)	Potassium carbonate	4 [hp_X]  in 50 mL
Delphinium staphisagria Seed (UNII: 00543AP1JV) (Delphinium staphisagria Seed - UNII:00543AP1JV)	Delphinium staphisagria Seed	4 [hp_X]  in 50 mL
Datura stramonium Flowering Top (UNII: ESJ6ZIS34B) (Datura stramonium Flowering Top - UNII:ESJ6ZIS34B)	Datura stramonium Flowering Top	10 [hp_X]  in 50 mL
Viburnum opulus Bark (UNII: T1UG6H6805) (Viburnum opulus Bark - UNII:T1UG6H6805)	Viburnum opulus Bark	1 [hp_X]  in 50 mL
Zanthoxylum Americanum Bark (UNII: A4KL1HMZ7T) (Zanthoxylum Americanum Bark - UNII:A4KL1HMZ7T)	Zanthoxylum Americanum Bark	3 [hp_X]  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59469-145-10	1 in 1 BOX	04/12/2008	06/30/2019
1		50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		04/12/2008	06/30/2019

Labeler - PEKANA Naturheilmittel GmbH (320344542)

Revised: 11/2019

Document Id: 3adbb68b-aa32-41d8-a9bf-2180dda1528d

34390-5

Set id: 89c3cf55-f514-4a39-9edf-2a70c8302346

Version: 4

Effective Time: 20191120

 

PEKANA Naturheilmittel GmbH