Respirasode Liquid
FDA Label NDC 43406-0089

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 Respirasode (NDC 43406-0089). 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, indications & usage, otc - purpose, dosage & administration, otc - keep out of reach of children, warnings, 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*) - equal amounts of: Bryonia 6C, 12C, 30C, Dulcamara 6C, 12C, 30C, Kali Carb 6C, 12C, 30C, Sanguinaria 6C, 12C, 30C, Belladonna 30C, Bromium 30C, Candida Alb 30C, Candida Parap 30C, Conium 30C, Lycopodium 30C, Pulsatilla 30C, Secale 30C, Silicea 30C, Sticta 30C, Sulphur 30C, Ustilago Maidis 30C

Indications & Usage

USES: Temporarily relieves cough, stuffy and dry nose, and/or symptoms related to cold.**

Otc - Purpose

USES: Temporarily relieves cough, stuffy and dry nose, and/or symptoms related to cold.**

Dosage & Administration

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

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 right away.

Warnings

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care 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.
  • A persistent cough may be a sign of a serious condition. If cough persists more than 1 week, tends to recur, or is accompanied by fever, rash, or headache, consult a doctor.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

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.

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

Package Label.Principal Display Panel

NDC:43406-0089-1

Respirasode

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Image Description (Respirasode)

Image Description (Respirasode)

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