PARAFFINUM- paraffinum 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

PARAFFINUM HPUS 1X and higher

USES

Children’S Constipation

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 9415 Burnet Road, Suite 312, Austin, TX 78758

image description

PARAFFINUM 
paraffinum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-0328
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PARAFFIN (UNII: I9O0E3H2ZE) (PARAFFIN - UNII:I9O0E3H2ZE) PARAFFIN1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15631-0328-0100 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
2NDC:15631-0328-1200 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
3NDC:15631-0328-2400 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
4NDC:15631-0328-3750 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
5NDC:15631-0328-42500 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
6NDC:15631-0328-512500 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
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(15631-0328) , label(15631-0328)

Revised: 3/2020
Document Id: a19b4d83-d0d8-2c7c-e053-2a95a90afa3f
Set id: c5782cd1-2e1f-4bc2-8ad5-4a5a015114b5
Version: 3
Effective Time: 20200324
 
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc