PASSIFLORA INCARNATA- passiflora incarnata pellet 
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc

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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ACTIVE INGREDIENT

PASSIFLORA INCARNATA HPUS 3X and higher

USES

USES: Temporary Relief - Difficulty Falling Asleep*

* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INDICATIONS

Condition listed above or as directed by the physician

DOSAGE

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.

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

As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

Keep this and all medication out of reach of children

INACTIVE INGREDIENTS

Sucrose

STORAGE

Store in a cool dark place

QUESTIONS OR COMMENTS

www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

Rxhomeo, Inc 3200 Commander Dr, Ste 100-W1, Carrollton, TX 75006 USA

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Label-Pellets

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carton-label

PASSIFLORA INCARNATA 
passiflora incarnata pellet
Product Information
Product TypeHUMAN OTC DRUGItem 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15631-0331-0100 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
2NDC:15631-0331-1200 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
3NDC:15631-0331-2400 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
4NDC:15631-0331-3750 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
5NDC:15631-0331-42500 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
6NDC:15631-0331-512500 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
7NDC:15631-0331-6500 in 1 PACKAGE; Type 0: Not a Combination Product08/23/2021
8NDC:15631-0331-71000 in 1 PACKAGE; Type 0: Not a Combination Product08/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/12/2015
Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
Establishment
NameAddressID/FEIBusiness Operations
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-0331) , label(15631-0331)

Revised: 10/2021
Document Id: cf04ac6b-3b6e-fc24-e053-2995a90a56d1
Set id: 3c2a9fa1-0d7a-48db-ac73-f6e74d0aba98
Version: 4
Effective Time: 20211023
 
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc