Constipation
FDA Label NDC 43406-0610

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc. for the product Constipation (NDC 43406-0610). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS (HPUS*): Magnesium Carbonicum 4X, Magnesium Muriaticum 4X, Aesculus Hippocastanum 12X, Alumen 12X, Alumina 12X, Bryonia Alba 12X, Nux Vomica 12X, Silicea 12X

Otc - Purpose

USES: Temporarily relieves great straining, large, dry, hard, knotty stools, &/or other symptoms of constipation.**

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

Indications & Usage

USES: Temporarily relieves great straining, large, dry, hard, knotty stools, &/or other symptoms of constipation.**

Warnings

WARNING:

  • Consult a physician for use in children under 12 years of age. 
  • IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

Dosage & Administration

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Inactive Ingredient

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Otc - Questions

Questions & Comments?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

References

*The  letters “HPUS” indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

Package Label.Principal Display Panel

NDC: 43406-0610-1

CONSTIPATION

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

UPC: 877730001030

* Please review the disclaimer below.