H PYLORI REMEDY- helicobacter pylori, liquid
Apotheca Company

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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Drug Facts:

ACTIVE INGREDIENTS: H. Pylori 15X, 20X, 30X, 60X, 90X, 120X, 150X, 200X, 500X, 1000X.

INDICATIONS: For the temporary relief of symptoms related to H. Pylori infection including upper abdominal pain or discomfort, gastric hemorrhage, loss of appetite, belching, nausea, vomiting and fatigue.

WARNINGS: Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

DIRECTIONS: 1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN. In case of overdose, contact physician or Poison Control Center right away.

Dist. By:

Deseret Biologicals, Inc.

469 Parkland Drive

Sandy, UT 84070

www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC 57520-0807-1

HOMEOPATHIC

H PYLORI REMEDY

1 FL OZ (30 ml)

H. Pylori Remedy

H PYLORI REMEDY
helicobacter pylori, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0807
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	15 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0807-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/12/2011	03/08/2017

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0807) , api manufacture(57520-0807) , label(57520-0807) , pack(57520-0807)

Revised: 11/2015

Document Id: b944f28b-12d4-4698-a1ae-a586f46b3a39

Set id: f7333dcf-a02d-49d7-8dc8-ba453ad57392

Version: 5

Effective Time: 20151119

Apotheca Company