RXHOMEO HOMEOPATHIC COMBO- rxhomeo homeopathic combo 
Rxhomeo Private Limited d.b.a.

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.

----------

ACTIVE INGREDIENT

PASSIFLORA INCARNATA HPUS 3X and higher

KALI PHOSPHORICUM HPUS 1X and Higher

USES

A homeopathic combination pack with two single remedies Passiflora Incarnata and Kali Phosphoricum for relief of sleeplessness.


Passiflora Incarnata; Uses: Passiflora Incarnata is a chief remedy for insomnia or sleeplessness. Passiflora helps in quietning the nervous system and induces normal sleep. Restlessness and wakeful sleep especially in the feeble, infants, and the aged with history of mental worries and over work.


Kali Phosphoricum;Uses: Kali Phosphoricum helps in insomnia or sleeplessness after worry or excitement from nervous causes. Also walking in sleep in children.

INDICATIONS

Condition listed above or as directed by the physician

DOSAGE

PELLETS included in the Combo

Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

TABLETS included in the Combo

Adults- Take 4 or 6 Tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

WARNINGS

This product is to be used for self-limiting conditions

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

Keep this and all medication out of reach of children

Do not use if capseal is broken or missing.

Close the cap tightly after use.

INACTIVE INGREDIENTS

Sucrose for Pellets.

Lactose for Tablets.

STORAGE

Store in a cool dark place

QUESTIONS OR COMMENTS

www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com
Rxhomeo, Inc 1504 Fairway Dr. Ste W 100 Lewisville, TX 75057 USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

RXHOMEO HOMEOPATHIC COMBO 
rxhomeo homeopathic combo kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-2483
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15631-2483-01 in 1 CONTAINER10/10/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1 1 
Part 2 1 
Part 1 of 2
PASSIFLORA INCARNATA 
passiflora incarnata pellet
Product Information
Item Code (Source)NDC:15631-0331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 2 of 2
KALI PHOSPHORICUM 
kali phosphoricum tablet
Product Information
Item Code (Source)NDC:15631-0612
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize3mm
FlavorImprint Code
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/10/2016
Labeler - Rxhomeo Private Limited d.b.a. (650833994)
Establishment
NameAddressID/FEIBusiness Operations
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-2483) , label(15631-2483)

Revised: 10/2016
Document Id: 239a2843-dc01-4048-993d-2bd29ddd4180
Set id: 8599654a-019f-43dc-8a74-839f8800ee69
Version: 1
Effective Time: 20161013
 
Rxhomeo Private Limited d.b.a.