Upper Respiratory Staph Strep Combination (Staphylococcus Aureus, Klebsiella Pneumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Inf -

UPPER RESPIRATORY STAPH STREP COMBINATION (STAPHYLOCOCCUS AUREUS, KLEBSIELLA PNEUMONIAE, ENTEROCOCCUS FAECALIS, PNEUMOCOCCINUM, STREPTOCOCCUS AGALACTIAE, STREPTOCOCCUS MUTANS, HAEMOPHILUS INF
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NDC	43742-0958-1
Set ID	47fa0657-a57e-40b5-9ce8-8715658fe829
Category	HUMAN OTC DRUG LABEL
Packager	Deseret Biologicals, Inc.
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENTS:

Staphylococcus Aureus 15X, 30X, 60X, 200X, Klebsiella Pneumoniae 15X, 30X, 200X, 12C, 30C, 60C, 200C, Enterococcus Faecalis 12C, 30C, 60C, 200C, Pneumococcinum 12C, 30C, 60C, 200C, Streptococcus Agalactiae 12C, 30C, 60C, 200C, Streptococcus Mutans 12C, 30C, 60C, 200C, Haemophilus Influenzae B 12C, 60C, 200C, Streptococcus Viridans 36C, 60C, 200C.
HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to upper respiratory infections including fever, cough and runny nose.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
WARNINGS:

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

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.
KEEP OUT OF REACH OF CHILDREN:

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

For temporary relief of symptoms related to upper respiratory infections including fever, cough and runny nose.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol
QUESTIONS:

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070 www.desbio.com
PACKAGE LABEL DISPLAY:

DESBIO

NDC 43742-0958-1

HOMEOPATHIC

UPPER RESPIRATORY

STAPH/STREP

COMBINATION

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

UPPER RESPIRATORY STAPH STREP COMBINATION
staphylococcus aureus, klebsiella pneumoniae, enterococcus faecalis, pneumococcinum, streptococcus agalactiae, streptococcus mutans, haemophilus influenzae b, streptococcus viridans liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43742-0958
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
STAPHYLOCOCCUS AUREUS (UNII: O478WX4004) (STAPHYLOCOCCUS AUREUS - UNII:O478WX4004)	STAPHYLOCOCCUS AUREUS	15 [hp_X] in 1 mL
KLEBSIELLA PNEUMONIAE (UNII: 09PA36CT5R) (KLEBSIELLA PNEUMONIAE - UNII:09PA36CT5R)	KLEBSIELLA PNEUMONIAE	15 [hp_X] in 1 mL
ENTEROCOCCUS FAECALIS (UNII: 15E04LZ9CT) (ENTEROCOCCUS FAECALIS - UNII:15E04LZ9CT)	ENTEROCOCCUS FAECALIS	12 [hp_C] in 1 mL
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2)	STREPTOCOCCUS PNEUMONIAE	12 [hp_C] in 1 mL
STREPTOCOCCUS AGALACTIAE (UNII: 2B3763S671) (STREPTOCOCCUS AGALACTIAE - UNII:2B3763S671)	STREPTOCOCCUS AGALACTIAE	12 [hp_C] in 1 mL
STREPTOCOCCUS MUTANS (UNII: 5C7J33MJJ1) (STREPTOCOCCUS MUTANS - UNII:5C7J33MJJ1)	STREPTOCOCCUS MUTANS	12 [hp_C] in 1 mL
HAEMOPHILUS INFLUENZAE TYPE B (UNII: F2TW0N64FI) (HAEMOPHILUS INFLUENZAE TYPE B - UNII:F2TW0N64FI)	HAEMOPHILUS INFLUENZAE TYPE B	12 [hp_C] in 1 mL
STREPTOCOCCUS VIRIDANS GROUP (UNII: NNV2379HKR) (STREPTOCOCCUS VIRIDANS GROUP - UNII:NNV2379HKR)	STREPTOCOCCUS VIRIDANS GROUP	36 [hp_C] 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:43742-0958-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/06/2017

Labeler - Deseret Biologicals, Inc. (940741853)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43742-0958) , api manufacture(43742-0958) , label(43742-0958) , pack(43742-0958)

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Medic

UPPER RESPIRATORY STAPH STREP COMBINATION (STAPHYLOCOCCUS AUREUS, KLEBSIELLA PNEUMONIAE, ENTEROCOCCUS FAECALIS, PNEUMOCOCCINUM, STREPTOCOCCUS AGALACTIAE, STREPTOCOCCUS MUTANS, HAEMOPHILUS INF

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