Spigelia Anthelmia
FDA Label NDC 15631-0409

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rxhomeo Private Limited D.b.a. Rxhomeo, Inc for the product Spigelia Anthelmia (NDC 15631-0409). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, uses, indications, dosage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

SPIGELIA ANTHELMIA HPUS 2X and higher

Uses

USES: Temporary Relief - Nasal Congestion*

* 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

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep this and all medication out of reach of children

Otc - Do Not Use

Do not use if capseal is broken or missing.

Close the cap tightly after use.

Inactive Ingredients

Sucrose

Storage

Store in a cool dark place

Package Label.Principal Display Panel

Mini-label (Mini Labels Pellets Fda15631 0409)

Mini-label (Mini Labels Pellets Fda15631 0409)

Label-pellets (Label Pellets Fda 15631 0409)

Label-pellets (Label Pellets Fda 15631 0409)

* Please review the disclaimer below.