Respirasode

Respirasode
SPL v2
SPL
SPL Set ID ce06327f-7e5e-420a-9b61-0d410f9e10d6
Route
ORAL
Published
Effective Date 2023-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bryonia Alba Root (30 [hp_C]) Solanum Dulcamara Top Carbonate Ion Sanguinaria Canadensis Root Atropa Belladonna Bromine Candida Albicans Candida Parapsilosis Conium Maculatum Flowering Top Lycopodium Clavatum Spore Anemone Pulsatilla Claviceps Purpurea Sclerotium Silicon Dioxide Lobaria Pulmonaria Sulfur Ustilago Maydis
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2012-05-22
Description

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

Medication Information

Warnings and Precautions

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.
Indications and Usage

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

Dosage and Administration

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

Description

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

Section 34093-5

*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.

Section 50565-1

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.

Section 51727-6

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

Section 51945-4

NDC:43406-0089-1

Respirasode

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1

QUESTIONS & COMMENTS?

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

Section 55105-1

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

Section 55106-9

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

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.
Section 34093-5 (34093-5)

*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.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

Section 51945-4 (51945-4)

NDC:43406-0089-1

Respirasode

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

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

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:09.770344 · Updated: 2026-03-14T23:17:34.743008